TC WIRE HOLDING FORCEPS LAT-JAW 170MM

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 LX176R - TC WIRE HOLDING FORCEPS LAT-JAW 170MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE JAW WAS BROKEN. DURING THE REMOVAL OF THE FOREARM OF A YOUNG GIRL, ONE OF THE TWO JAWS HAS BROKE INSIDE THE ARM: SMALL PIECES AND SEVERAL RESIDUES INSIDE. THE SURGEON HAS REMOVED ALL THE RESIDUES WITH A DISSECTING FORCEPS. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. 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. EXPLANATION AND RATIONALE: BASED ON THE STATEMENT IN THE COMPLAINT, A THIRD-PARTY REPAIR IS TO BE ASSUMED: AFTER IDENTIFICATION OF THE FORCEPS BY THE PHARMACISTS RESPONSIBLE FOR STERILIZATION. WE HAVE FOUND QUOTES FOR REPAIR OF THE FORCEPS JAWS. AS A RESULT, THE RESPONSIBILITY FOR HANDLING THIS INCIDENT NO LONGER RESTS WITH YOU. PLEASE ACCEPT OUR APOLOGIES FOR THE INCONVENIENCE AND MY DELAYED RESPONSE DUE TO A DIFFICULTY IN IDENTIFYING AND PROVIDING A HISTORY OF THE FORCEPS. THE CANCELLATION OF THIS STATEMENT, WHICH INVOLVED B. BRAUN, WILL BE FORWARDED TO ANSM IMMEDIATELY. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS, A MAINTENANCE-RELATED ROOT CAUSE OF THE PROBLEM IS MOST PROBABLE. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.