BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE OSCILLATING SAW ATTACHMENT F/532.0

    MDR report key: 3191544 · Received June 26, 2013

    Report

    Report Number
    2520274-2013-03427
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THE BLADE ATTACHMENT WOULD NOT SECURELY MATE TO THE HAND PIECE THE DHR WAS REVIEWED AND THE RECORD INDICATES THE PARTS WERE MANUFACTURED IN CONFORMANCE WITH SYNTHES SPECIFICATIONS. THE PRODUCT INVESTIGATION AND VISUAL INSPECTION DID NOT SHOW ANY DISCREPANCIES FROM THE SPECIFICATION. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. A CAPA DETERMINATION REQUEST HAS BEEN INITIATED.

    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)(4)

    Additional Manufacturer Narrative · 1

    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 USED ON THE RIGHT KNEE OF A NEUTERED CANINE. FEMALE. (B)(6)

    Description of Event or Problem · 1

    THE OSCILLATING SAW BLADE WOULD NOT STAY SECURELY ATTACHED TO THE HANDPIECE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WENT TO THE CLINIC ON (B)(6) 2011 WITH PARTIAL RIGHT TEAR IN CRANIAL CRUCIATE LIGAMENT (CCL). DURING THE TIBIAL PLATEAU LEVELING OSTEOTOMY SURGERY, THE SAW ATTACHMENT PIECE BROKE OFF FROM THE POWER TOOL (COLIBRI HANDLE) WHILE IN USE. THE DEVICE WAS ATTACHED IN THE UNLOCK MODE AND THEN LOCKED. THE ATTACHMENT PRODUCES HEAT DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290086 LARGE OSCILLATING SAW ATTACHMENT F/532.0 HWE SYNTHES (USA) BRANDYWINE 1266

    Patients

    Seq Age Sex Outcome Treatment
    1