BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 16482290 · Received March 3, 2023

    Report

    Report Number
    8030965-2023-02648
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    GDZ
    UDI-DI
    10886982189943
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT FOR THE FOLLOWING PRODUCTS: 03.043.029; 2023519 319.006; H521672 319.006; A4GJ568 03.010.523; 9570803 03.010.523; L759640 03.010.523; 31P5810 03.010.523; 9850771 03.010.491; H884724 03.037.017; 9764853 393.10; UNK 03.033.001; L750728 03.118.111; T981020 TRACKING NUMBER: 770750148967. NO ADDITIONAL INFORMATION IS KNOWN. HOWEVER, IT COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THE PRODUCT WAS RETURNED TO DEPUY SYNTHESE FOR EVALUATION. THE DEPUY SYNTHESE TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WAS BENT FROM THE NEEDLE, ALSO THE DEVICE WAS FOUND CRACKED BY THE HANDLE. THE PROTECTING SLEEVE WAS NOT RETURNED. ALSO THE HANDLE WAS FOUND TO BE DISCOLORED. THE OBSERVED CONDITION WAS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. AFTER A VISUAL INSPECTION PER GUIDANCE PROVIDED IN WINDCHILL DOCUMENT IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE WAS DISCOLORED AND BENT FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. AS PART OF DEPUY SYNTHESE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT WAS WORN FROM REPEATED USE AND SERVICING. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY DRAWING/SPECIFICATIONS REVIEWED THE FOLLOWING DOCUMENT WAS REVIEWED: DEVICE HISTORY LOT PART # 319.006 SYNTHESE LOT # A4GJ568 SUPPLIER LOT # N/A RELEASE TO WAREHOUSE DATE: (B)(6) 1997 MANUFACTURED BY: SYNTHESE BRANDYWINE NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH, NULL, DEVICE HISTORY REVIEW , REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 0

    IT WAS REPORTED THAT THE VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS THAT THE REUSABLE INSTRUMENT DEVICE WAS DISCOLORED AND BENT FROM REPEATED USE AND SERVICING, ALSO THE DEVICE WAS FOUND CRACKED BY THE HANDLE.. THE PROTECTING SLEEVE WAS NOT RETURNED. NO OTHER ISSUES WERE FOUND. NO ADDITIONAL INFORMATION IS KNOWN. HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913078 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS HANDLE, SCALPEL GDZ SYNTHES GMBH 319.006 A4GJ568 10886982189943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AIM-ARM RADIOLUC| BLADE/SCREW GUIDE SLEEVE| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| DRIVING CAP/THREADED| DRIVING CAP/THREADED| DRIVING CAP/THREADED| DRIVING CAP/THREADED| LONG SCALPEL HANDLE| RADIOLUCENT INSERTION HANDLE FRN| SILICONE HNDL/QC ROTATING CAP| UNIVERSAL CHUCK WITH T-HANDLE