DERMATOME AN HANDPIECE

Additional Manufacturer Narrative

(B)(4). D10. CONCOMITANT MEDICAL PRODUCTS: 8870N100, WIDTH PLATE, NEUTRAL, 1 IN., LOT: UNK, SERIAL: UNK. 8870N200, WIDTH PLATE, NEUTRAL, 2 IN., LOT: UNK, SERIAL: UNK. 8870N300, WIDTH PLATE, NEUTRAL, 3 IN., LOT: UNK, SERIAL: UNK. 8870N400, WIDTH PLATE, NEUTRAL, 4 IN., LOT: UNK, SERIAL: UNK. 00880100200, DERMATOME HOSE, LOT: UNK, SERIAL: UNK. 88700500, SCREWDRIVER, LOT: UNK, SERIAL: UNK. 88700300, AUTOCLAVE CASE, LOT: UNK, SERIAL: UNK. 88701805, WIDTH PLATE SCREWS CONTAINS: 1 PACK OF 5 EACH, LOT: UNK, SERIAL: UNK. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THAT THE DEVICE WAS NOT HARVESTING SKIN CORRECTLY. CARRIED OUT PREVENTIVE MAINTENANCE AND CALIBRATION TO RESOLVE THE REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING SURGERY THE PLATE AND WHOLE DERMATOME WERE MISALIGNED. PATIENT IMPACT/HARM ARE UNKNOWN. DURING DEVICE EVALUATION, THE DEVICE WAS NOT CUTTING PROPERLY. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.