BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY-CAS F/532.033 F/532.001+532.010

    MDR report key: 3191895 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03491
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    March 14, 2012
    Report Date
    March 14, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    MOQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE MANUFACTURE DATE WAS 12/21/2010. ADDITIONAL EVALUATION WAS PERFORMED: THE BATTERY CASING WAS ANALYZED. NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FRACTURE FACE OF THE BROKEN PINS WAS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. BASED ON THE PROVIDED INFORMATION, THE CAUSE OF THIS OCCURRENCE COULD NOT BE DETERMINED. IT CAN ONLY BE ASSUMED THAT IT FELL OR WAS HIT BY ANOTHER INSTRUMENT THAT DAMAGED THE PINS. NO PRODUCT FAULT COULD BE DETECTED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOLDING PINS OF THE BATTERY FROM THE COLIBRI POWER TOOL ARE BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290446 BATTERY-CAS F/532.033 F/532.001+532.010 MOQ SYNTHES USA 9156

    Patients

    Seq Age Sex Outcome Treatment
    1