BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3677082 · Received March 13, 2014

    Report

    Report Number
    8030965-2014-10034
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SERVICE HISTORY OF THE PAST SIX MONTHS FROM THE AWARENESS DATE WAS REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED. THE ITEM HAS NOT BEEN IN FOR SERVICE FOR THE PAST SIX MONTHS. THERE IS NO INFORMATION RELEVANT TO THE CURRENT COMPLAINED ISSUE. POWER TOOL EVALUATION WAS ALSO COMPLETED ON THIS DEVICE. THE CUSTOMER DID NOT ALLEGE OR IDENTIFY ANY SPECIFIC DEFICIENCY; IT WAS OBSERVED DURING ROUTINE SERVICE AND REPAIR OF THE (LOT 003221) SMALL BATTERY DRIVE THAT THE DEVICE MAKES AN UNUSUAL NOISE, AND TRIGGERS ARE STICKY. THIS IS MOST LIKELY DUE TO MECHANICAL COMPONENT FAILURE DUE TO USAGE WEAR OVER TIME. 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 DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE IS AN INSTRUMENT AND NOT IMPLANTED/EXPLANTED. A ROUTINE SERVICE AND REPAIR OF THE DEVICE WAS CONDUCTED; IT CONCLUDED THE HANDPIECE OF THE SMALL BATTERY DRIVE IS MAKING AN UNUSUAL NOISE AND THE TRIGGERS ARE STICKY. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT INVESTIGATION IS ON-GOING. A REVIEW OF SERVICE AND REPAIR HISTORY RECORDS AND ADDITIONAL EVALUATION/POWER TOOL EVALUATION HAVE BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2014 BY THE SERVICE REPAIR TECHNICIAN THAT DURING ROUTINE SERVICE AND REPAIR OF THE DEVICE IT WAS DISCOVERED THAT THE HANDPIECE OF THE SMALL BATTERY DRIVE (PART 532.010, LOT 003221) IS MAKING AN UNUSUAL NOISE AND THE TRIGGERS ARE STICKY. NO REPORT OF PATIENT AND PROCEDURE HARM NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT EVENT IS FOR ONE POWER DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150291 SMALL BATTERY DRIVE INSTR, SURGICAL,ORTHOPEDIC,AC-POWER MOTOR/ACCESS & ATTACH HWE SYNTHES OBERDORF 003221/5826824

    Patients

    Seq Age Sex Outcome Treatment
    1