PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE

Additional Manufacturer Narrative

NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN THE EVENT OCCURRED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. PART NUMBER: 399.481, LOT NUMBER: T926225. DATE OF MANUFACTURE: 02JUN2008. (B)(4). DESCRIPTION OF DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD FROM THE MANUFACTURING SITE (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. 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.

Description of Event or Problem

IT WAS REPORTED THAT SEVERAL INSTRUMENTS AT THE FACILITY ARE DISCOLORED. THE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER, THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE (STRAIGHT EDGE), THE PERIOSTEAL ELEVATOR 3MM CURVED BLADE (ROUND EDGE), AND THE HOLDING SLEEVE. WHEN PEEL PACKED, THE HANDLES ARE LEACHING A BROWN SUBSTANCE ON THE BACKING OF THE PEEL PACK. THE HANDLES HAVE A DULL, ROUGH FINISH. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR A CURVED BLADE (ROUND EDGE) ELEVATOR. (B)(4).

Additional Manufacturer Narrative

THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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.

Additional Manufacturer Narrative

A PRODUCT INVESTIGATION WAS PERFORMED. THE RETURNED DEVICE WAS EXAMINED AND THE COMPLAINT CONDITION WAS NOT ABLE TO BE CONFIRMED AS NO BROWN LEACHING SUBSTANCE WAS IDENTIFIED AND THE PEEL PACK WAS NOT RETURNED. THE PHENOLIC MATERIAL HANDLE DOES HAVE TEXTURE FOR TACTILE FEEL BY DESIGN, BUT THE REPORTED CONDITION OF ROUGH AND DULL ARE NOT CONFIRMED. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD FROM THE MANUFACTURING SITE (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. THE MATERIAL AND RELEVANT MATERIAL PROPERTIES WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): PERIOSTEAL ELEVATOR DRAWING WERE REVIEWED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. IT IS POSSIBLE THAT THE FACILITY HAS USED STERILIZATION PARAMETERS OUTSIDE OF SYNTHES RECOMMENDATIONS ON THE RETURNED 9+ YEAR OLD INSTRUMENT CAUSING THE REPORTED COMPLAINT CONDITION BUT THIS CANNOT BE CONFIRMED BASED ON THE RECEIVED CONDITION OF THE DEVICE AT CUSTOMER QUALITY (CQ). SYNTHES RECOMMENDATIONS FOR INSTRUMENT STERILIZATION PARAMETERS CAN BE FOUND IN THE "INSTRUCTIONS FOR PROCESSING SYNTHES REUSABLE MEDICAL DEVICES - INSTRUMENTS, INSTRUMENT TRAYS AND CASES" PER RELEVANT TECHNIQUE GUIDE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. CORRECTED DATA: ADDRESS. 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.