The Next Era in GI Surgery BioDynamixTM

AnastomosisThe Colon Ring

Clinical Training Team

FORMS ANDPROTOCOLS

DATA COLLECTION

• It is important for us to gather and document information apropos to the Preop and Intraop Data Forms.

• In order to document communication of appropriate instructions and information concerning use of the ColonRingTM (Preop Form) and to demonstrate results in sufficient patients (Intraop Form), completion of these forms is our only way to obtain meaningful data.

• Most of our reps have expressed regret at not having enough controlled clinical data, but gathering accurate commercial data should go a long way to demonstrate meaningful results that can be shared with our surgeons.

• Also, since virtually all of the early users among our surgeons will acknowledge the importance of obtaining that kind of data, they will most likely be willing to assist us in providing that information.

• I would suggest the following routine:

PREOP DATA FORM

• During one of your initial visits with a surgeon interested and willing to use the ColonRingTM, discuss the items listed on the Preop Form with the surgeon and complete the form electronically as soon as possible after the visit.

• Once completed, the form should be emailed to Joanna McNamara and Wendell Eicher so the data can be filed.

• This Preop data is important for:

– Identifying appropriate contact information for the surgeon.

– Verifying what has been discussed with the surgeon as well as when.

– Allowing clinical coverage personnel to have access to contact information and usage preferences when you are not present.

PREOP DATA FORM

..\..\..\Clinical\Surgical Cases\CAR 27 DataBase\Individual Case Data\Forms\Field_Data_Preop.doc

INTRAOP DATA FORM

• When you are present for a case, gather the appropriate data requested on the Intraop Data Form during the case, asking clarification from the surgeon as necessary, and complete the form electronically as soon as possible after the visit.

• Once completed, the form should be emailed to Joanna McNamara and Wendell Eicher so the data can be filed.

• This Intraop data is important for:

– Identifying appropriate contact information for the surgeon for subsequent follow-up as necessary.

– Documenting essential information from the case which may help in:• Allowing better analysis of overall outcome data.• Allowing better understanding of any subsequent adverse event.

INTRAOP DATA FORM

..\..\..\Clinical\Surgical Cases\CAR 27 DataBase\Individual Case Data\Forms\Field_Data_Intraop.doc

Phase III Evaluation Form

• This form will be used to evaluate personnel during their Phase III training.

• Any fully certified NiTi employee will be expected to complete this form (in Excel format it may be completed electronically) and email it back to me for recording it on file.

• ..\..\Certifications\Certification Process\Phase III Evaluations\BLANK PHASE III EVAL FORM.xls

NiTi Surgical Field Training May 11th, 2011

May 2011John McInroy

Customer Complaints

What is a Complaint?

Definition of a Complaint from QA-13-02

Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, efficacy or performance of a device after it is released for distribution.

Why do the FDA and other organizations take complaints so seriously?

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What is NOT a Complaint?

• Deficiencies that, unequivocally, are not caused by NiTi Surgical Solutions Ltd. Products,

• Commercial Dispute,

• Deficiencies that are reported during R&D validation stage (i.e., before their formal release for marketing),

• Inquiries for information.

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FDA Complaint Non-Conformances

• The number one reason for writing a non-conformance was because complaint handling procedures were inadequate.

– All complaints are processed in a uniform and timely manner;

– Oral complaints are documented upon receipt; and

– Complaints are evaluated to determine whether the complaint represents an event that must be reported to the FDA.

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FDA Observations (cited in warning letters)

“…Failure to include known or reasonably known information on the FDA Form report such as patient information: (1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth;(3) Patient gender; and (4) Patient weight, as required …”

“…provisions for documenting facts associated with the complaint (e.g. complainant address and telephone number, device identification and control numbers) …”

...“You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money

penalties”....12

Complaint Receipt

Reporting 5 day or

30 day?Investigation

Close Complaint

Corrective / Preventive

Action?

Yes

Initiate CAPA

Report MDR

No

Yes

No

Trending

NiTi US Function

NiTi Israel Functions

Complaint Process Flow

Complaint Ack. letter

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US Field Complaint Responsibilities

• Complete Customer Complaint form No. 1 (F-13-02-1)

• First 2 pages are a must for all complaints !

• Only when it is a clinical issue complaint, complete App. A (3 pages) of the form

• Forward information to appropriate CS personnel

• Report ASAP – time is critical (MDR reporting)14

Specific Issues Requiring Attention

• Complete every field or use N/A

• Lack of date consistency (DD/MMM/YY)

• Omission of contact information

• Only use CURRENT revision of form

• Double check that what was filled-in is appropriate for the form fields

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Specific Issues Requiring Attention (cont)

• Keep email referencing a single device/event if possible

• Do not change the forms, as they are written

• Corrections, if hand written should be made with one line through, initial and date (all docs)

F-13-02-1 Rev 06 Customer Complaint Form No.1

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ADVERSE EVENT REPORT

..\..\..\Clinical\Surgical Cases\Customer Complaint Forms\F-13-02-1 Rev 06 Customer Complaint Form No. 1 For Users.doc

Conclusion

• Doing it “right the first time” can save time and money

• Being “out of compliance” can have harsh consequences

• Process starts with US Sales, continues to Israel CS/QA/RA and mostly ends up at FDA.

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