BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 6811833 · Received August 22, 2017

    Report

    Report Number
    2530088-2017-10256
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 2, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    UDI-DI
    10886982196088
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART 357.377, LOT 5010025 DHR REVIEW FOR PART: #357.377 -SYNTHES LOT # 5010025 RELEASE TO WAREHOUSE DATE: 18OCT2005 EXPIRATION DATE: NA SUPPLIER: (B)(4). MRR # (B)(4) WAS GENERATED ON PART 357.377 LOT 5010025 ON JULY 20, 2005. IT WAS REPORTED THAT THE HELICAL BLADE COUPLING SCREW WAS RECEIVED IN THE BRANDYWINE FACILITY WITH A BAD WELD UNDER THE HEAD OF SCREW ON THE INSTRUMENT. 111 INSTRUMENTS WERE RECEIVED AND IT WAS REPORTED THAT THE INSTRUMENT HAD A ROUGH WELD. OF THE 111 INSTRUMENTS THAT WERE INSPECTED 8 INSTRUMENTS WERE SHIPPED BACK TO THE SUPPLIER FOR RE-WORK. INSTRUMENTS WERE RETURNED AND RE-INSPECT WITH NO VISUAL NON-CONFORMITIES. THE RELEVANCE OF THE COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS(S) SHOWED THAT THERE MAY BE A POTENTIAL ISSUE DURING THE MANUFACTURE OF THE PRODUCT THAT MIGHT HAVE CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 DURING INSERTION OF TROCHANTERIC FIXATION NAIL (TFN) HELICAL BLADE, THE END OF THE HELICAL BLADE COUPLING SCREW BROKE OFF. MALFUNCTION RESULTED IN SURGICAL DELAY OF 15 MINUTES TO DETERMINE ALTERNATIVE APPROACH. PATIENT OUTCOME WAS SATISFACTORY. THIS COMPLAINT INVOLVES ONE DEVICE. CONCOMITANT DEVICES: HELICAL BLADE INSERTER, PART # UNKNOWN, LOT # UNKNOWN, OTY: 1, AIMING ARM, PART # UNKNOWN, LOT # UNKNOWN, QTY: 1, CONNECTING SCREW, PART # UNKNOWN, LOT # UNKNOWN, QTY: 1, INSERTION HANDLE, PART # UNKNOWN, LOT # UNKNOWN, QTY: 1, NAIL, PART # UNKNOWN, LOT # UNKNOWN, QTY: 1. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590767 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES BRANDYWINE 5010025 10886982196088

    Patients

    Seq Age Sex Outcome Treatment
    1