KERRISON 15MM NOIR 130DEG UP 200MM 3MM
Received Jul 6, 2020 · Event occurred Jun 10, 2020
Report 9610612-2020-00244 · MDR key 10233996
Device
Product problems
- Material Deformation
- Material Deformation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
- No Consequences Or Impact To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00245 (400475184 FK982R).
Additional Manufacturer Narrative
BASED UPON INVESTIGATION RESULTS, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE DUE TO RISK FILE- NO MALFUNCTION OR SERIOUS INJURY. UPDATED D9: DATE RECEIVED BY MANUFACTURER UPDATED H6 CODES . INVESTIGATION RESULTS: VISUAL INVESTIGATION: INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY. THE PUNCHES SHOW CLEAR SIGNS OF DEFORMATION ON THE CUTTING EDGE OF THE UPPER SLIDER, WHICH IS BENT-UP IN. THE FAILURES FOUND IN OUR INVESTIGATION ARE CLEAR SIGNS OF AN OVERLOAD SITUATION DURING THE PROCEDURE ITSELF. WE WERE NOT ABLE TO DETECT ANY HINT FOR A MATERIAL DEFECT OR A PRODUCTION ERROR. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) HAVE BEEN CHECKED FOR ALL LEADING DEVICES LOT NUMBERS AND THE PRODUCTS FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 2(5) X PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.
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 KERRISON DEVICES. IT WAS REPORTED THAT THE TIP OF THE PRODUCT IS CURVED UPWARD, BENT WHILE CUTTING BONE. THERE WAS NO PATIENT HARM. THIS EVENT/MALFUNCTION PROLONGED THE SURGERY FOR 5 MINUTES. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00245 (B)(4).
Description of Event or Problem
ASSOCIATED MEDWATCH-REPORTS: 9610612-2020-00244 (400475182 FK982B). 9610612-2020-00245 (400475184 FK982R).
Additional Manufacturer Narrative
INVESTIGATION RESULTS: THE DEVICES WERE NOT AVAILABLE FOR INVESTIGATION. DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. DUE TO THE DESCRIBED FAILURE PATTERN AND OUR KNOWLEDGE FROM THE COMPLAINT DATABASE IT IS LIKELY, THAT THE ROOT CAUSE OF THE BENT UP CUTTING EDGE IS USAGE RELATED, E.G. DUE TO IMPROPER HANDLING OR AN OVERLOAD SITUATION. TO AVOID SUCH DAMAGES IT IS IMPORTANT TO CHECK THE PRODUCT PRIOR TO USE AS DESCRIBED IN THE IFU AND IT IS IMPORTANT TO AVOID OVERLOAD SITUATIONS: ACCORDING TO THE IFU THE FOLLOWING POINTS MUST BE OBSERVED: " ALWAYS CARRY OUT A FUNCTION CHECK PRIOR TO USING THE PRODUCT. AVOID OVERSTRAINING BY TURNING OR LEVERING (ESPECIALLY APPLIES TO KERRISON BONE PUNCHES WITH THIN FOOT PLATE)."