BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 5820186 · Received July 25, 2016

    Report

    Report Number
    1719045-2016-10567
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    July 10, 2016
    Report Date
    July 11, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A MATERIAL RECORD REVIEW WAS CREATED FOR VISUAL INSPECTION SHOWING A ROUGH/BAD WELD UNDER HEAD OF SCREW. REWORK WAS COMPLETED, NONE WERE SCRAPPED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE 357.377 LOT NUMBER 5010025 HELICAL BLADE COUPLING SCREW WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY OVER TEN YEARS OF CONSISTENT USE AND POSSIBLE OFF ANGLE HAMMER STRIKES; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. PER THE TECHNIQUE GUIDE, THE 357.377 HELICAL BLADE COUPLING SCREW IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY. THIS CONDITION IS CONFIRMED; THE PROXIMAL KNURLED HEAD HAS SHEARED OFF THE SHAFT OF THE DEVICE. IT IS LIKELY THAT OVER TEN YEARS OF CONSISTENT USE AND POSSIBLE OFF ANGLE HAMMER STRIKES HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN OCTOBER 2005 AND IS OVER TEN YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH SEVERAL MARKINGS FROM HAMMER STRIKES ON THE PROXIMAL KNURLED HEAD. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. UPON REVIEW OF THE DEVICE HISTORY RECORD, A MATERIAL RECORD REPORT (MRR) WAS CREATED FOR VISUAL INSPECTION SHOWING A ROUGH WELD UNDER THE HEAD OF THE SCREW. THIS MRR IS VERY UNLIKELY TO HAVE CONTRIBUTED TO THE COMPLAINT CONDITION AS THE DEVICE HAS FUNCTIONED IN THE FIELD FOR OVER TEN YEARS AND THE MRR DENOTES THE CONDITION TO BE A VISUAL RATHER THAN A FUNCTIONAL NON-CONFORMANCE. IT IS LIKELY THAT OVER TEN YEARS OF CONSISTENT USE AND POSSIBLE OFF ANGLE HAMMER STRIKES HAS LED TO THIS COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE TO REPAIR A FEMUR FRACTURE ON (B)(6) 2016 USING A TROCHANTERIC FIXATION NAIL (TFN) SYSTEM. WHILE IMPACTING THE HELICAL BLADE INSERTION ASSEMBLY FOR IMPLANTATION OF THE BLADE, THE SURGEON NOTED THAT THE HELICAL BLADE COUPLING SCREW HAD SHEARED OFF AND WAS BROKEN. A FIFTEEN MINUTES DELAY WAS REPORTED WHILE THE SURGEON REMOVED THE BROKEN PIECE OF THE COUPLING SCREW FROM THE BLADE AND PROCEEDED TO COMPLETE THE PROCEDURE. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: BLADE INSERTER (PART #: 357.372, LOT #: UNKNOWN, QTY: 1) AND HELICAL BLADE (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 1), IMPACTING TOOL (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 1). THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473352 HELICAL BLADE COUPLING SCREW MISC. ORTHO SURGICAL INSTR. LXH SYNTHES BRANDYWINE 5010025

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPACTING TOOL(PART#,LOT# UNKNOWN)