KERRISON DETACH 130DG UP 200MM 1MM THIN

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT: FK961B - KERRISON DETACH 130DG UP 200MM 1MM THIN VIA INFORMATION RECEIVED FROM MW5178960. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TIP OF THE INSTRUMENT BROKE OFF INTO THE PATIENT'S WOUND. THE TIP WAS RECOVERED AND THERE WAS NO REPORTED PATIENT HARM. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: MW5178960. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: NO DEATH OR SERIOUS INJURY. NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON BATCH HISTORY REVIEW, HISTORICAL DATA ANALYSIS AND EVENT DESCRIPTION. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR ALL LEADING DEVICE(S) LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER(S) WITH THIS ERROR PATTERN. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: MW5178960. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS NOT CONSIDERED / DEEMED REPORTABLE FOR THE FOLLOWING REASON: - NO DEATH OR SERIOUS INJURY. - NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE CURRENT INFORMATION, A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A DESIGN-, MANUFACTURING- AND/OR MATERIAL-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT SAMPLE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.