KERRISON DETACH.130DEG UP 200MM 5MM THIN

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT FK965R - KERRISON DETACH. 130DEG UP 200MM 5MM THIN VIA INFORMATION RECEIVED FROM MW (B)(4). ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE WAS BENDING DURING USE (TOP SLIDER PORTION). THIS OCCURRED DURING SPINAL SURGERY. A DIFFERENT KERRISON WAS USED TO COMPLETE THE PROCEDURE. FURTHER DETAILS WERE NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL REPORTER: (B)(6). INVESTIGATION RESULTS: THE VISUAL INSPECTION REVEALED A DEFORMED CUTTING PART OF THE WANGLER. FURTHER ANALYSES OF THIS ERROR PATTERN WERE CARRIED OUT AS PART OF AESCULAP AG INTERNAL REFERENCE NO. (B)(4). THE REPEATING FAILURE MODE WAS CONFIRMED BASED ON THE RECEIVED SAMPLE FAILURE DESCRIPTION AND BASED ON PHOTO DOCUMENTATION. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE 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: (B)(4) 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 THE REPORTING DECISION IS BASED UPON THE REVIEW OF THE APPLICABLE RISK ANALYSIS. THE REVIEW OF THE RISK ANALYSIS REVEALED THAT THE APPLICABLE FAILURE MODE IS RATED WITH A SEVERITY OF 1(5). BASED UPON RISK MANAGEMENT REVIEW, WE CURRENTLY CONCLUDE THAT EVEN IF THE REPORTED FAILURE IS TO REOCCUR, NO SERIOUS INJURY FOR PATIENT, USER OR THIRD PARTY IS TO BE EXPECTED. CONCLUSION/PREVENTIVE MEASURES: THE REPORTED DAMAGE OF THE PRODUCT COULD BE CONFIRMED. A FINAL ROOT CAUSE FOR THIS FAILURE COULD NOT BE DETERMINED. BASED ON CONTINUOUS IMPROVEMENT, A OPTIMIZED CHANGE IN DESIGN WAS MADE.