BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL BATTERY DRIVE

    MDR report key: 3911285 · Received July 2, 2014

    Report

    Report Number
    3009450871-2014-10236
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 6, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE CUSTOMER CALLED IN A SERVICE REQUEST FOR THIS ITEM ON 12.05.2014 FOR: COLIBRI SEND IN FOR EVALUATION AND REPAIR. DEVICE IS NOISY AND MAKES A GRINDING SOUND. DURING THE PREVIOUS 6 MONTHS, THE ITEM WAS RETURNED ON: 12.05.2014 DUE TO MOTOR SEIZED, ROUGH RUNNING, DEFECT. THE FOLLOWING COMPLAINT DESCRIPTION HAS BEEN REPORTED: COLIBRI SEND IN FOR EVALUATION AND REPAIR. DEVICE IS NOISY AND MAKES A GRINDING SOUND. THE INVESTIGATION IS BASED ON THE SERVICE & REPAIR RECORD RECEIVED. THE DEVICE FAILURE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THE SERVICE HISTORY REVIEW SHOWS THAT THE PREVIOUS SERVICE CONDITION FROM (B)(4) 2014 IS RELEVANT TO THE CURRENT COMPLAINT ISSUE. DEVICE WAS REPAIRED DUE TO: MOTOR SEIZED, ROUGH RUNNING, DEFECT, THEN IT CAME BACK THE SERVICE CENTER ONE MONTH LATER BUT NO FAILURE COULD BE IDENTIFIED. AFTER PRE-REPAIR DIAGNOSTIC ASSESSMENT, THE DEVICE HAS NOT BEEN SERVICED. THE SERVICE TECHNICIAN NOTED THE FOLLOWING ACTION TAKEN: NO REPAIR OKAY. DURING THE PRE-REPAIR DIAGNOSTIC ASSESSMENT THE SERVICE TECHNICIAN IDENTIFIED THE FOLLOWING FAILURE: NO FAILURE IDENTIFIED. THE PROBABLE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE NO FAILURE IDENTIFIED.. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DEVICE IS NOISY AND MAKES A GRINDING SOUND. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385721 SMALL BATTERY DRIVE INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH HWE DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1