BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSH-PULL REDUCTION DEVICE

    MDR report key: 2931315 · Received January 28, 2013

    Report

    Report Number
    2520274-2013-00671
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO SYNTHES FOR EVALUATION ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT EVALUATION REPORT STATES THAT THE DESIGNS ARE ADEQUATE FOR THEIR INTENDED USES AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT FOR IS INVALID FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INFORMATION RECEIVED FROM CONSULTANT. PRECISION EDGE MANUFACTURED THE PUSH-PULL REDUCTION DEVICE, PART 324.024, LOT PE01642, THREE PURCHASE ORDERS WERE REVIEWED FOR THIS DHR. THE FOLLOWING APPLIES TO ALL THREE POS: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND THE PRODUCT CONFORMED TO ALL REQUIREMENTS AS NOTED IN THE CERTIFICATE OF COMPLIANCE, DATED (B)(4) 2012. THE LOTS WERE INSPECTED AND CONFORMED TO THE SYNTHES INSPECTION SHEET. THERE WERE NO NONCONFORMITIES FOR ANY LOTS.

    Description of Event or Problem · 1

    DURING A SURGERY FOR A PROXIMAL RIGHT HUMERUS FRACTURE ON (B)(6) 2013, THE SURGEON WAS USING THE PUSH-PULL REDUCTION DEVICE AND THE DRILL TIP TO THE THREADS OF THE DEVICE SNAPPED OFF INTO THE PATIENTS HUMERUS AND REMAINS THERE. THE SURGEON DID NOT ATTEMPT TO REMOVE THE PIECE WHICH IS APPROXIMATELY ONE INCH IN LENGTH. AS THE SURGEON WAS PUTTING IN THE KIRSCHNER WIRE, IT GLANCED OFF THE METAL THAT WAS LEFT IN THE PATIENT AND A PIECE OF THE WIRE BROKE OFF AND ALSO REMAINS IN THE PATIENT; APPROXIMATELY AN INCH IN LENGTH. AT FIRST GLANCE, IT WAS THOUGHT THE WIRE WAS ONLY BENT BUT THEN WAS DETERMINED TO HAVE BROKEN OFF. THIS WAS VERIFIED BY X-RAY. THE SURGERY WAS NOT PROLONGED AND THE SURGEON DID NOT SEEM CONCERNED. THE SALES CONSULTANT REPORTED THAT THE CIRCULATING NURSE WAS ALSO SUBMITTING A REPORT. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36590 PUSH-PULL REDUCTION DEVICE PUSH-PULL REDUCTION DEVICE FZX SYNTHES USA PE01642

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR KIRSCHNER WIRE