ACCULAN 3TI DERMATOME

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 GA670 - ACCULAN 3TI DERMATOME. ACCORDING TO THE COMPLAINT DESCRIPTION, THE DEVICE GRIPPED THE SKIN INTRAOPERATIVELY. PATIENT HARM WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

Additional Manufacturer Narrative

AFTER REVIEW OF THE INVESTIGATION RESULTS, THE COMPLAINT WAS RE-ASSESSED AND FOUND TO NO LONGER BE REPORTABLE; PRA WAS ADJUSTED AND SEVERITY WAS DECREASED TO 2(5). INVESTIGATION: THE INVESTIGATION HAS BEEN CARRIED-OUT BY THE AESCULAP TECHNICAL SERVICES (ATS). THE INVESTIGATION SHOWED THAT THE PLATE GA670258 AND MEASUREMENT BAR GB229415 HAVE SEVERAL DAMAGES. THE AXLE GA643222 IS DAMAGED. BATCH HISTORY REVIEW: SINCE A REPAIR WAS PERFORMED AND THIS WAS IDENTIFIED AS THE CAUSE, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT NECESSARY. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE; SEVERITY 2(5) AND PROBABILITY X(5). EXPLANATION AND RATIONALE: A CLEAR CONCLUSION CANNOT BE DRAWN. THE DAMAGES AT THE PLATE GA670258 AND MEASUREMENT BAR GB229415 ARE PROBABLY ORIGINATED BY FALLING OR IMPACT, POSSIBLY THIS HAS LED TO A MISALIGNMENT OF THE DERMATOME HEAD. SINCE THE MAINTENANCE DATE HAS TO BE CARRIED OUT IN AUGUST 2022, IT COULD BE POSSIBLE THAT WEAR AND TEAR AND / OR A LACK OF MAINTENANCE LED TO THE DESCRIBED PROBLEM. HOWEVER, THIS IS ONLY SPECULATIVE. CONCLUSION/PREVENTIVE MEASURES: BASED ON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.