BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER J-LATCH COUPLING

    MDR report key: 3934883 · Received July 15, 2014

    Report

    Report Number
    3009450871-2014-10247
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: (B)(6). SERVICE HISTORY REVIEW OF THE DEVICE HAS BEEN PERFORMED. THE REVIEW INDICATES THAT THE DEVICE HAS NOT BEEN SERVICED DURING THE PAST 6 MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE INVESTIGATION IS BASED ON THE SERVICE & REPAIR RECORD (SRR) RECEIVED. THE DEVICE FAILURE REPORTED BY THE CUSTOMER COULD BE CONFIRMED. THE SERVICE HISTORY REVIEW SHOWS NO PREVIOUS SERVICE CONDITIONS RELEVANT TO THE CURRENT COMPLAINT ISSUE. THE SERVICE TECHNICIAN NOTED THE FOLLOWING ACTION TAKEN: ACTIVITY EXCHANGE REPLACEMENT. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FOLLOWING FAILURE: GENERAL, WORN-OUT, DRILL INSERTION IS DEFECT. OFFERED REPLACEMENT. THE PROBABLE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE NORMAL WEAR. THE DEVICE WAS RETURNED TO THE CUSTOMER 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: THE EVENT TOOK PLACE IN THE WEEK OF (B)(6). DURING A PROCEDURE WITH A PATIENT, (EXACT DATE UNKNOWN,) THE SURGEON WANTED TO SWITCH THE BURR BECAUSE IT BROKE OFF, A SPARE WAS USED AND THE PATIENT WAS NOT AFFECTED. THE REMAINING PIECE OF THE BURR IS STILL IN POSSESSION OF THE CUSTOMER. THIS IS 1 OF 1 FOR COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413481 STRYKER J-LATCH COUPLING INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS MA1048

    Patients

    Seq Age Sex Outcome Treatment
    1