PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: MANUFACTURING DATE: WEEK 7 IN 2002. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICES. PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE P/N (B)(4), LOT# A7LA44. CUSTOMER QUALITY (CQ) ENGINEERING INVESTIGATION: THIS COMPLAINT IS UNCONFIRMED. THE HANDLES OF THE RETURNED DEVICES WERE NOT LEAKING AND DID NOT EXHIBIT ANY RESIDUE DURING VISUAL INSPECTION AT THE CQ LOCATION. THE REPORTED ISSUE OF ¿GREASY¿ RESIDUE IDENTIFIED ON THE HANDLES WAS NOT SEEN INTERNALLY WHEN THE RETURNED DEVICES WERE RE-PROCESSED INTERNALLY PER THE REQUIRED PRODUCT REPROCESSING (CLEANING AND STERILIZATION) STEPS. THE COMPLAINT ISSUE COULD NOT BE REPLICATED. VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEWS WERE PERFORMED AS PART OF THIS INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TEST: THE DEVICES HANDLES ARE NOT WOODEN BUT MADE OF PHENOLIC LE GRADE MATERIAL. THE DEVICES DID NOT EXHIBIT ANY SIGNS OF DAMAGE ON THE HANDLES OR ON THE REST OF THE DEVICE BODY. THIS COMPLAINT IS UNCONFIRMED. THE HANDLES OF THE RETURNED DEVICES WERE NOT FOUND TO BE LEAKING AND DID NOT EXHIBIT ANY RESIDUE DURING VISUAL INSPECTION AT THE CQ LOCATION. THE OVERALL BALANCE OF THE RETURNED DEVICES IS IN A GOOD AND FUNCTIONAL CONDITION. DHR REVIEW FOR PART #399.481, LOT# A7LA44: THE DHR IS NO LONGER AVAILABLE IN TUTTLINGEN DUE TO THE AGE OF THE INSTRUMENT (OVER 15 YEARS OLD). HARDNESS AND MATERIAL REVIEW IS NOT APPLICABLE AT THIS TIME FOR THE ABOVE DEVICE AS THE DEVICE IS MORE THAN 14 YEARS OLD AND HENCE HAVE UNDERGONE A CONSIDERABLE CUMULATIVE WEAR DURING THEIR SERVICE PERIOD. THE COMPLAINT CONDITION IS MOST PROBABLY NOT AN OUTCOME OF THE HARDNESS OR THE MATERIAL OF THE ABOVE TWO DEVICES. DRAWING REVIEW: THE RETURNED DEVICES WERE FOUND TO BE MANUFACTURED PER THE APPLICABLE MFG DRAWINGS. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. UNDER A SIMILAR COMPLAINT THAT HAD BEEN LODGED AGAINST DEVICE HANDLES COMPOSED OF THE SAME MATERIAL (PHENOLIC LE GRADE), THE RETURNED HANDLE WAS SENT FOR RESIDUE ANALYSIS VIA FOURIER TRANSFORMED INFRARED SPECTROPHOTOMETRY (FTIR) BY DIAMOND ATTENUATED TOTAL REFLECTION (DATR). THE ANALYSIS REVEALED THE PRESENCE OF THE FOLLOWING EXTRACTABLE RESIDUES: PHENOLIC COMPOUND, AUTOCLAVE PACKAGING AND COTTON SPECTRA, ALL OF WHICH CAN BE ATTRIBUTED TO THE DEVICE HISTORY. ALTHOUGH THE EXACT CAUSE FOR THIS COMPLAINT CONDITION COULD NOT BE DETERMINED, IT IS LIKELY A RESULT OF WEAR/REPEATED STERILIZATION CYCLES COUPLED WITH THE DEVICE BEING SUBJECTED TO FORCES OUTSIDE APPROVED LIMITS, AND NOT THE DEVICE'S DESIGN. . THE BLEEDING RESIDUE REPORTED BY THE CUSTOMER IS LIKELY CAUSED BY A FAILURE AT THE CUSTOMER TO PROPERLY REPROCESS THE PRODUCT. IT IS PROBABLY THE RESULT OF THE PRODUCT NOT BEING CORRECTLY REPROCESSED. DHR REVIEW: P/N (B)(4), LOT# A7LA44. MANUFACTURING DATE: WEEK 7 IN 2002. THE DHR IS NO LONGER AVAILABLE IN TUTTLINGEN DUE TO THE AGE OF THE INSTRUMENT (OVER 15 YEARS OLD). THEREFORE THE EXACT DATE OF MANUFACTURE IS UNKNOWN. 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

THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DATE OF EVENT IS UNKNOWN. 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. REPORTER PHONE NUMBER EXTENSION IS REPORTED AS (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS REQUESTER FOR PART # 399.481 / LOT # A7IA30: MANUFACTURING DATE: WEEK 30 1999, LOCATION: (B)(4), A DHR FOR THIS DEVICE IS NO LONGER AVAILABLE DUE TO THA AGE OF THE DEVICE (APPROX. 18 YEARS OLD). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 SCREW DRIVER WOODEN HANDLES FROM A MODULAR HAND SYSTEM ARE BLEEDING AND LEAVING STAINS ON THE LIDS AND CAUSING A CONCERN. THERE IS NO PATIENT INVOLVED AS THIS IS HAPPENING IN STERILE PROCESSING DEPARTMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 3MM CURVED BLADE - ROUND EDGE THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).