BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM ANGLE ATTACHMENT, BLACK, MAX

    MDR report key: 4157204 · Received October 9, 2014

    Report

    Report Number
    1045834-2014-13906
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Report Date
    March 20, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS USED FOR TREATMENT; NOT DIAGNOSIS. ADDITIONAL NARRATIVE: CORRECTIVE DATA: DEVICE IS AN INSTRUMENT, NOT IMPLANTED/EXPLANTED. (B)(4) 2014, DATA OBSERVED. CHANGED 501K FROM K011444 TO K831756. 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

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES (B)(4) AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO SYNTHES OUS SERVICE AND REPAIR FILES LEGACY REVIEW/REMEDIATION PROTOCOL-COMPLAINT HANDLING AND MDR REPORTING. DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED THE DRIVE SHAFT WAS STRONGLY WORN OUT AND BENT, THE TEMPERATURE WAS ABOVE SPECIFICATION, THE W2 INSERTION WAS VERY STIFF, AND THE BALL BEARINGS WERE DEFECTIVE. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE BALL BEARINGS, DRIVE SHAFT, BEVEL WHEELS, AND SAFETY CATCH WERE REPLACED. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER ON 04/09/2013.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED FOR REPAIR. TECHNICIAN NOTED VIBRATION TEST FAILED AND TEMPERATURE TEST FAILED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636334 8CM ANGLE ATTACHMENT, BLACK, MAX DRILL, BURRS, TREPHINES, & ACCESSORIES (SIMPLE, POWERED) HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1