BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROCATING SAW ATTACHMENT

    MDR report key: 3782152 · Received April 30, 2014

    Report

    Report Number
    3009450871-2014-10120
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 3, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFA
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT 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 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. AFTER PRE-REPAIR DIAGNOSTIC ASSESSMENT, THE DEVICE HAS BEEN SERVICED. THE SERVICE TECHNICIAN NOTED THE FOLLOWING ACTION TAKEN TIW_ MAINTENANCE, INSPECTION. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FOLLOWING FAILURE: SERVICE. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. (B)(6). 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE, REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DEVICE, REPROCATING SAW ATTACHMENT-COUPLING MECHANISM IS DEFECTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260429 RECIPROCATING SAW ATTACHMENT BLADE,SAW,GENERAL & PLASTIC SURGERY,SURGICAL GFA DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1