KERRISON DETACH.130DEG UP 200MM 5MM THIN

Additional Manufacturer Narrative

ADDITIONAL REPORTER: (B)(6). INVESTIGATION RESULTS: DURING THE VISUAL INSPECTION, IT WAS FOUND THAT THE JAW CLOSES AFTER ACTUATION OF THE HANDLE. THE CUTTING TEST CARRIED OUT WAS SUCCESSFUL. THE REPEATING FAILURE MODE WAS CONFIRMED BASED ON PHOTO DOCUMENTATION AND BASED ON FUNCTION TEST. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND THE PRODUCT FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS ONE SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER WITH THIS ERROR PATTERN. THIS MEDWATCH IS BEEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: 2400930000-2023-8024. 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, IT IS CURRENTLY CONCLUDED 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 FAILURE OF THE PRODUCT COULD NOT BE CONFIRMED. THE INVESTIGATION SHOWED THAT THE PRODUCT IS ACCORDING TO SPECIFICATIONS. BASED UPON INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED.

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 2400930000-2023-8024. 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).