PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE

Description of Event or Problem

IT WAS REPORTED THAT THE WOODEN HANDLE OF THE PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE IS BROKEN OFF. IT WAS DISCOVERED IN THE STERILE PROCESSING DEPARTMENT; THERE WAS NOT PATIENT INVOLVEMENT. DURING EVALUATION OF THE DEVICE, IT WAS NOTED THAT THE MAJORITY OF THE HANDLE MATERIAL HAS SEPARATED AWAY FROM THE SHAFT OF THE DEVICE, AND THE REMAINING PORTION IS CRACKED ABOUT THE PIN. THIS IS REPORT 1 OF 1 FOR (B)(4).

Additional Manufacturer Narrative

DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SERVICE HISTORY REVIEW: LOT A7KA50/4367923: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. THE CUSTOMER REPORTED THE HANDLE WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE BLADE WAS BURRED. WORN OUT PARTS IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: ONE PERIOSTEAL ELEVATOR 6MM (PART 399.36, MANUFACTURER LOT A7KA50, SYNTHES LOT 4367923, MANUFACTURED JANUARY 2002) WAS RETURNED. UPON RECEIPT OF THIS DEVICE IT WAS SEEN THAT A MAJORITY OF THE HANDLE MATERIAL HAS SEPARATED AWAY FROM THE SHAFT OF THE DEVICE, AND THE REMAINING PORTION IS CRACKED ABOUT THE PIN. THIS COMPLAINT IS CONFIRMED. THE DRAWINGS FOR THIS DEVICE WERE REVIEWED AND NO DIMENSIONAL NON-CONFORMANCES WERE FOUND FOR THIS DEVICE. GIVEN THE AGE OF THIS INSTRUMENT, THE MATERIAL OF THE HANDLE, AND THE EVIDENT SIGNS OF USE, THIS COMPLAINT CAN LIKELY BE ATTRIBUTED TO REGULAR USE OVER TIME COUPLED WITH REPEATED STERILIZATION CYCLES. THE DESIGN OF THIS DEVICE IS ADEQUATE FOR ITS INTENDED USE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.