DERMATOME BLADES F/WAGNER DERMAT.STERILE

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED. D9 - PRODUCT RECEIPT. D10- INVOLVED COMPONENTS. H3 - YES, EVALUATION. H6 - CODES UPDATED. INVESTIGATION FINDINGS: VISUAL INSPECTION: DURING THE INVESTIGATION OF GA670 SN: (B)(6) (AESCULAP AG REF. NO. (B)(4)), SEVERAL DEVIATIONS WERE IDENTIFIED, PRIMARILY RELATED TO MAINTENANCE AND HANDLING. THE DEVICE HAD EXCEEDED ITS SCHEDULED MAINTENANCE INTERVAL (DUE JULY 2024), WHICH MAY HAVE CONTRIBUTED TO INCREASED WEAR. RESIDUES AND SURFACE DISCOLORATION WERE OBSERVED ON THE DERMATOME PLATE (GA670258) NEAR THE FRONT PINS, INDICATING POSSIBLE DEFICIENCIES IN REPROCESSING. THE GUIDE PLATE (GA670209) SHOWED FRICTION MARKS ON THE INNER FRONT SURFACE AND SEVERE IMPACT DAMAGE ON THE LEFT SIDE, SUGGESTING IMPROPER HANDLING OR ACCIDENTAL MECHANICAL STRESS. A SLIGHT MISALIGNMENT OF THE CUTTING GAP WAS MEASURED AT APPROXIMATELY +0.07 MM ON THE LEFT SIDE IN CUTTING DIRECTION; HOWEVER, THIS DEVIATION DID NOT AFFECT THE CUTTING PERFORMANCE, AS CONFIRMED BY TESTS USING THE REFERENCE MEDIUM. FURTHER OBSERVATIONS INCLUDED TOOL MARKS ON THE ECCENTRIC BUSHING (GB229220) AND THE NUT OF THE FLAP ROD (GA643345), INDICATING NON-STANDARD MANUAL INTERVENTIONS OR UNAUTHORIZED REPAIRS. DESPITE THESE FINDINGS, THE DEVICE PERFORMED WITHIN SPECIFICATION DURING FUNCTIONAL TESTING, AND THE DEVIATIONS WERE DETERMINED TO BE COSMETIC OR PROCEDURAL IN NATURE. THEREFORE, THE PRODUCT DID NOT CONTRIBUTE TO THE CLAIMED FUNCTIONAL DEVIATION. DURING THE INVESTIGATION OF GA670 SN: (B)(6) (AESCULAP AG REF. NO. (B)(4)), SEVERAL DEVIATIONS WERE IDENTIFIED, PRIMARILY RELATED TO MAINTENANCE AND HANDLING. THE DEVICE HAD EXCEEDED ITS SCHEDULED MAINTENANCE INTERVAL (DUE AUGUST 2024), WHICH MAY HAVE CONTRIBUTED TO INCREASED WEAR AND MINOR MISALIGNMENT. RESIDUES AND SURFACE DISCOLORATION WERE OBSERVED ON THE DERMATOME PLATE (GA670258) NEAR THE FRONT PINS, INDICATING POSSIBLE DEFICIENCIES IN REPROCESSING. THE GUIDE PLATE (GA670209) SHOWED DAMAGE ON THE FRONT EDGE, FRICTION MARKS ON THE INNER FRONT SURFACE, AND IMPACT MARKS, ALL OF WHICH SUGGEST IMPROPER HANDLING OR MECHANICAL STRESS DURING USE. A SLIGHT MISALIGNMENT OF THE CUTTING GAP WAS MEASURED AT APPROXIMATELY +0.04 MM ON THE RIGHT SIDE IN CUTTING DIRECTION; HOWEVER, THIS DEVIATION DID NOT AFFECT THE CUTTING PERFORMANCE, AS CONFIRMED BY TESTS USING THE REFERENCE MEDIUM. ADDITIONAL FINDINGS INCLUDED TOOL MARKS ON THE ECCENTRIC BUSHING NUT (GB229220) AND THE NUT OF THE FLAP ROD (GA643345), INDICATING NON-STANDARD MANUAL INTERVENTIONS. FURTHERMORE, THE MARKING ON THE FLAP ROD (GA643817) WAS NO LONGER LEGIBLE, WHICH COMPROMISES TRACEABILITY. DESPITE THESE OBSERVATIONS, THE DEVICE PERFORMED WITHIN SPECIFICATION DURING FUNCTIONAL TESTING. THE DEVIATIONS WERE DETERMINED TO BE COSMETIC OR PROCEDURAL IN NATURE AND DID NOT CONTRIBUTE TO THE CLAIMED FUNCTIONAL DEVIATION. THE CUSTOMER HAD COMPLAINED ABOUT THREE 3 BLADES BUT PROVIDED ONLY ONE FOR INVESTIGATION. THE ONE BLADE WHICH WAS PROVIDED IS REGISTERED (UNDER AESCULAP AG REF. NO. (B)(4).). DUE TO MISSING INFORMATION AND ORIGINAL PACKAGING, IT WAS NOT POSSIBLE TO ASSIGN THE BLADE TO A SPECIFIC BATCH. CUTTING TEST WITH THE PROVIDED BLADE SHOWED NO DEVIATION IN CUTTING PERFORMANCE. BLADE EXHIBITED THREE DISTINCT DAMAGES ON THE CUTTING EDGE. BATCH HISTORY REVIEW: DEVICE HISTORY RECORDS WERE CHECKED FOR ALL RELEVANT LOT NUMBERS AND CONFIRMED COMPLIANCE WITH SPECIFICATIONS AT THE TIME OF PRODUCTION. NO SIMILAR COMPLAINTS WERE REPORTED FOR THESE LOT NUMBERS. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. CONCLUSION/PREVENTIVE MEASURES: THE EXACT ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. THE CUSTOMER'S COMPLAINT REGARDING CUTTING PERFORMANCE COULD NOT BE CONFIRMED. ALL FUNCTIONAL TESTS, INCLUDING CUTTING TRIALS AND DIMENSIONAL INSPECTIONS, DEMONSTRATED THAT THE DEVICES AND BLADES OPERATED WITHIN SPECIFICATION AND SHOWED NO SIGNIFICANT DEVIATION IN PERFORMANCE. THE DEVIATIONS IDENTIFIED DURING THE INVESTIGATION WERE PRIMARILY RELATED TO OVERDUE MAINTENANCE, IMPROPER REPROCESSING, AND HANDLING ISSUES. THESE FINDINGS WERE COSMETIC OR PROCEDURAL IN NATURE AND DID NOT AFFECT THE CUTTING FUNCTIONALITY OF THE PRODUCTS. SPECIFICALLY, BOTH GA670 DEVICES HAD EXCEEDED THEIR SCHEDULED MAINTENANCE INTERVALS, WHICH MAY HAVE CONTRIBUTED TO INCREASED WEAR AND MINOR MISALIGNMENTS. REGARDING THE GB228R BLADES, THE ABSENCE OF ORIGINAL PACKAGING PREVENTED BATCH TRACEABILITY. ALTHOUGH THREE DISTINCT DAMAGES WERE OBSERVED ON THE CUTTING EDGE, ALL DIMENSIONAL CHECKS CONFIRMED COMPLIANCE WITH SPECIFICATIONS, AND CUTTING TESTS SHOWED NO FUNCTIONAL DEVIATION. NOTE: PLEASE TAKE CARE OF THE CORRECT HANDLING AND MAINTENANCE STEPS ACCORDING TO THE IFU (INSTRUCTIONS FOR USE) VALID AT THE TIME OF USE. BASED UPON THE INVESTIGATION, A NON-CONFORMANCE WAS INITIATED.

Description of Event or Problem

UPDATE: THIS MEDICAL DEVICE IS NOW CONSIDERED TO BE AN INVOLVED COMPONENT. ASSOCIATED MEDWATCH REPORTS: GA670 (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00229). GA670 (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00234). INVOLVED COMPONENTS: GB228R/ DERMATOME BLADES F/WAGNER DERMAT.STERILE (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00237). GB228R/DERMATOME BLADES F/WAGNER DERMAT.STERILE (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00238). GB228R/ DERMATOME BLADES F/WAGNER DERMAT.STERILE (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00243).

Description of Event or Problem

UPDATE: ASSOCIATED MEDWATCH REPORTS: GA670 (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00229). GA670 (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00234). GB228R (AESCULAP AG REFERENCE NO. (B)(4):9610612-2025-00237). GB228R (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00238). GB228R (AESCULAP AG REFERENCE NO. (B)(4); 9610612-2025-00243).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5 - DESCRIPTION UPDATED.

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 PRODUCT GB228R - DERMATOME BLADES F/WAGNER DERMAT.STERILE. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SKIN GRAFT COULD NOT BE REMOVED PROPERLY, RESULTING IN TEMPORARY INJURY TO THE PATIENT. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4). ASSOCIATED MEDWATCH REPORTS: GA670 (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00229). GA670 (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00234). GB228R (AESCULAP AG REFERENCE NO. (B)(4):9610612-2025-00237). GB228R (AESCULAP AG REFERENCE NO. (B)(4): 9610612-2025-00238).