BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND

    MDR report key: 18142854 · Received November 15, 2023

    Report

    Report Number
    8030965-2023-14409
    Event Type
    Malfunction
    Date Received
    November 15, 2023
    Date of Event
    September 25, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    UDI-DI
    07611819187481
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, 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. H10 ADDITIONAL NARRATIVE: E1: INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE. H3, H4, H6 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT HAND (03.505.004 / 8202894) HAD THE DISTAL TREADED TIP DEFORMED AND EXHIBITS SCRATCHES. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES A DIMENSIONAL INSPECTION FOR THE HAND WAS UNABLE TO BE PERFORMED DUE TO POST MANUFACTURING DAMAGE. A COMPLETE FUNCTIONAL TEST WAS NOT PERFORMED SINCE THE REPORTED MATING DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, BASED ON THE DAMAGE OF THE THREADED CONNECTION TIP, IT IS REASONABLE THAT THE OBSERVED CONDITION PREVENTS THE DEVICE FROM ASSEMBLING ITS MATING DEVICE AS INTENDED. . AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE HAND WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. 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? YES, REVIEWED DIMENSIONAL INSPECTION: N/A. DEVICE HISTORY PRODUCT CODE: 03.505.004. LOT NUMBER : 8202894. RELEASE TO WAREHOUSE DATE : 01.DEC.2020. EXPIRATION DATE : NA. SUPPLIER: DIENER AG PRECISION MACHINING. MANUFACTURING SITE: WERK SELZACH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A PLATE REMOVAL SURGERY (SSRO) ON (B)(6) 2023, OPERATION STAFF ASSEMBLED THE HANDLE BEFORE STERILIZATION, AND NOTICED A SCRATCH ON THE CONNECTION PART WITH THE SHAFT. ALTHOUGH THE STAFF TRIED TO ASSEMBLE THE DEVICE, IT WAS NOT ABLE TO BE ATTACHED PROPERLY BECAUSE OF THE SCRATCH. THE SALES REPRESENTATIVE ALSO CONFIRMED THE SCRATCH AND POOR CONNECTION OF THE DEVICE. THE SALES REPRESENTATIVE PREPARED THE CNT-5 SET INSTEAD OF THE DEVICE IN QUESTION FOR SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. UPON MANUFACTURER INVESTIGATION OF THE DEVICE, IT WAS DETERMINED THAT DISTAL TREADED TIP WAS DEFORMED AND EXHIBITS SCRATCHES. THIS REPORT IS FOR (B)(4) FOR THE HAND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329860 HAND SCREWDRIVER HXX SYNTHES GMBH 8202894 07611819187481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - PLATES: TRAUMA