BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RATCHETING HANDLE WITH QUICK COUPLING

    MDR report key: 4357734 · Received December 23, 2014

    Report

    Report Number
    1719045-2014-10699
    Event Type
    Malfunction
    Date Received
    December 23, 2014
    Date of Event
    November 26, 2014
    Report Date
    November 26, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REPORTED: (B)(4) PRECISION MEDICAL INSTRUMENTS (NOW OWNED BY (B)(4)) MANUFACTURED THE RATCHETING HANDLE WITH QUICK COUPLE, P/N 03.100.032, AND LOT #5182822 (SUPPLIER LOT # 5616565B06) ON PO #(B)(4), FOR (B)(4) PIECES DELIVERED (B)(6) 2006. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED (B)(6) 2006 AND SYNTHES FINAL INSPECTION SHEET # (B)(4). THE PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(6) 2006. (B)(4) WAS ISSUED ON (B)(6) 2006 FOR ONE PART FAILING SAMPLE INSPECTION; (B)(4) SORT RESULTED IN ZERO NONCONFORMANCES, AND THE (B)(4) WAS CLOSED ON (B)(6) 2006. THE RATCHETING HANDLE WITH QUICK COUPLE WAS MADE TO THE SYNTHES DRAWING P/N 03.100.032, (B)(4), RELEASED ON (B)(6) 2005. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE RATCHETING HANDLE WITH QUICK COUPLING WAS RECEIVED INTACT. THE DEVICE SHOWS MODERATE WEAR WITH SEVERAL SCRAPE MARKS ALONG THE DISTAL METAL PORTION OF THE DEVICE. THE DISTAL METAL PORTION IS NO LONGER ATTACHED TO THE PHENOLIC HANDLE AND CAN BE EASILY SEPARATED. THE DEVICE IS MISSING A PIN OR SCREW THAT WOULD HOLD BOTH PIECES TOGETHER. THE DESIGN OF THE DEVICE WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED.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 · 1

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

    Description of Event or Problem · 1

    A 30 SECOND DELAY DURING THE PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845922 RATCHETING HANDLE WITH QUICK COUPLING MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 561656B06

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR