BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE COUPLING SCREW

    MDR report key: 6580089 · Received May 19, 2017

    Report

    Report Number
    2530088-2017-10116
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    April 23, 2017
    Report Date
    April 23, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    UDI-DI
    10886982196088
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS CONFIRMED. THE DEVICE WAS RECEIVED BROKEN IN TWO (2) PIECES. THE PROXIMAL KNOB HAS SHEARED OFF THE SHAFT AT THE WELD LOCATION. THE REMAINDER OF THE DEVICE SHOWS WEAR CONSISTENT WITH OVER ELEVEN (11) YEARS OF USE (BEING HAMMERED ON BY TECHNIQUE). NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED DEVICE IS A REUSABLE INSTRUMENT AVAILABLE FOR USE IN THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM TO FACILITATE HEAD ELEMENT (HELICAL BLADE AND LAG SCREW) INSERTION. THE RELEVANT HELICAL BLADE COUPLING SCREW ASSEMBLY DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. MOST LIKELY DUE TO CUMULATIVE WEAR FOR THIS ELEVEN (11) YEAR OLD REUSABLE CANNULATED DEVICE THAT TRANSMITS FORCE FROM HAMMER BLOWS PER TECHNIQUE. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW FOR PART # 357.377, SUPPLIER LOT # 5010026. RELEASE TO WAREHOUSE DATE: 08-AUG-2005. SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELICAL BLADE COUPLING SCREW CRACKED AT THE TOP PORTION OF THE SCREW DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2017. REPORTEDLY, THE SURGEON CONNECTED THE HELICAL BLADE COUPLING SCREW TO THE HELICAL BLADE INSERTER AND WHEN HE HAMMERED THE COUPLING SCREW WITH A MALLET, IT CRACKED AND BROKE IN TWO PIECES. THERE WERE REPORTEDLY NO FRAGMENTS GENERATED. THE THREADED PORTION OF THE COUPLING SCREW REMAINED IN THE INSERTER. THE HELICAL BLADE WAS FULLY INSERTED AND IN THE APPROPRIATE, DESIRED LOCATION, AS SUCH, THE DEVICE WAS NO LONGER NEEDED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAYS, ADDITIONAL MEDICAL INTERVENTION OR HARM TO THE PATIENT. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: MALLET (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), HELICAL BLADE INSERTER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HELICAL BLADE COUPLING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359453 HELICAL BLADE COUPLING SCREW MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 5010026 10886982196088

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR