BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL WITH PALM HANDLE

    MDR report key: 4238809 · Received November 8, 2014

    Report

    Report Number
    1719045-2014-10512
    Event Type
    Malfunction
    Date Received
    November 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(6). TELEFLEX MEDICAL (PRESENTLY TECOMET KENOSHA) MANUFACTURED THE AWL WITH PALM HANDLE, P/N 388.656, AND LOT NUMBER 6452224 FOR PO 1182239. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE (DATED 1011/10) INDICATES THE PARTS WERE MANUFACTURED TO P/N 388.656, REVISION ¿B¿ AND MET THE REQUIRED SPECIFICATIONS. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER 388IF656, REVISION ¿E¿ (COMPLETED 10/14/10). NO MATERIAL REVIEW REPORTS OR NONCONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. P/N 388.656 IS MADE FROM DRAWING, 388.656, REVISION ¿B¿, RELEASED ON JUNE 19, 2002. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE AWL TIP WAS BROKEN; THE FRAGMENT IS NOT WITH THE COMPLAINT. TELEFLEX MEDICAL, INC. MANUFACTURED THE LARGE HANDLED AWL, P/N 388.656, AND LOT NUMBER 6452224 ON PO 1182239 DATED OCTOBER 13, 2011. DUE TO AN UNKNOWN CAUSE, THE AWL TIP WAS BROKEN; THE FRAGMENT IS NOT WITH THE COMPLAINT. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF COMPLIANCE (DATED OCTOBER 11, 2010 FOR 103 PIECES) AND WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET #388IF656, REVISION ¿E¿. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS NOT MANUFACTURING-RELATED AND IS CONSIDERED UNCONFIRMED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A SURGERY FOR A LUMBAR DECOMPRESSION AND FUSION, WHILE THE SURGEON WAS WORKING IN AN UNKNOWN SPINE LEVEL THE AWL INSTRUMENT WITH PALM HANDLES AND TWO LONG HANDLE SLEEVE INSTRUMENTS BROKE. THE TIPS BROKE OFF INSTRUMENTS DURING SURGERY. IT WAS REPORTED THAT THERE WAS NO DELAY IN SURGERY WITH NO IMPACT TO THE PATIENT. SURGERY WAS COMPLETED WITH ANOTHER INSTRUMENT THAT WAS AVAILABLE IN THE OPERATING ROOM. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721313 AWL WITH PALM HANDLE AWL HWJ SYNTHES MONUMENT 6452224

    Patients

    Seq Age Sex Outcome Treatment
    1