BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILICONE HNDL/QC ROTATING CAP

    MDR report key: 16482385 · Received March 3, 2023

    Report

    Report Number
    8030965-2023-02650
    Event Type
    Malfunction
    Date Received
    March 3, 2023
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    UDI-DI
    10886982073686
    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). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 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 SUBJECT DEVICE HAS BEEN RECEIVED AT DEPUY SYNTHESE FOR EVALUATION. THE DEPUY SYNTHESE TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SILICONE HNDL/QC ROTATING CAP WAS BROKEN FROM THE CAP OF THE TIP. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EXAMINATION. NO OTHER ISSUES WERE FOUND. A DIMENSIONAL INSPECTION FOR THE SILICONE HNDL/QC ROTATING CAP WAS NOT PERFORMED AS IS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. 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 THE SILICONE HNDL/QC ROTATING CAP WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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 SURVEILLANCE ACTIVITIES. DRAWING/SPECIFICATIONS REVIEWED THE FOLLOWING SOURCE CONTROLLED DRAWINGS REFLECTING THE CURRENT AND MANUFACTURED REVISIONS WERE REVIEWED: DIMENSIONAL INSPECTION: N/A DEVICE HISTORY LOT PART # 03.118.111 SYNTHESE LOT #T981020 SUPPLIER LOT # T981020 RELEASE TO WAREHOUSE DATE:(B)(6) 2013, SUPPLIER : SYNTHESE TUTTLINGEN NO NCRS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY BATCH, NULL, DEVICE HISTORY 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 THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT FOR THE FOLLOWING PRODUCTS: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SILICONE HNDL/QC ROTATING CAP WAS BROKEN FROM THE CAP OF THE TIP. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EXAMINATION. 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) SILICONE HNDL/QC ROTATING CAP THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001425 SILICONE HNDL/QC ROTATING CAP FORCEPS HTD SYNTHES GMBH 03.118.111 T981020 10886982073686

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AIM-ARM RADIOLUC| BLADE/SCREW GUIDE SLEEVE| DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS| 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| UNIVERSAL CHUCK WITH T-HANDLE