BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE/SCREW GUIDE SLEEVE

    MDR report key: 6375297 · Received March 2, 2017

    Report

    Report Number
    9612488-2017-10083
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 6, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    FZX
    UDI-DI
    10886982070333
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-2214-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE DATE: JAN 30, 2015. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE 03.037.024 LOT NUMBER T111987 HELICAL BLADE INSERTER AND 03.037.017 LOT NUMBER 9351397 BLADE/SCREW GUIDE SLEEVE WERE RETURNED AND REPORTED TO HAVE BECOME STUCK TOGETHER DURING INSERTION AND TO HAVE BECOME DEFORMED. THIS COMPLAINT CONDITION WAS LIKELY CAUSED BY TWO YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, DEVICE HISTORY RECORD REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT IS CONFIRMED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. PER THE TECHNIQUE GUIDE, THE 03.037.024 HELICAL BLADE INSERTER AND 03.037.017 BLADE/SCREW GUIDE SLEEVE ARE INSTRUMENTS ROUTINELY USED IN THE TFN ADVANCED PROXIMAL FEMORAL NAILING SYSTEM. THE DEVICES WERE RETURNED AND REPORTED TO HAVE BECOME STUCK TOGETHER DURING INSERTION AND TO HAVE BECOME DEFORMED. THIS CONDITION IS CONFIRMED; THE INNER CIRCUMFERENTIAL EDGE OF THE PROXIMAL END OF THE GUIDE SLEEVE IS SEVERELY INDENTED AND DEFORMED. THE BALL BEARINGS ON THE INSERTER CATCH IN THE INDENTATIONS AND DON¿T ALLOW THE INSERTER TO PASS ALL THE WAY THROUGH THE GUIDE SLEEVE. IT IS LIKELY THAT OVER TWO YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE INSERTER WAS MANUFACTURED IN FEBRUARY 2015 AND IS OVER TWO YEARS OLD. THE GUIDE SLEEVE WAS MANUFACTURED IN JANUARY 2015 AND IS OVER TWO YEARS OLD. THE BALANCE OF EACH OF THE RETURNED DEVICES IS IN FAIRLY WORN CONDITION CONSISTENT WITH FREQUENT REPEATED USE. THE RELEVANT DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICES DOES AGREE WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT CONDITION FOR THESE DEVICES CAN BE REPLICATED. UPON REVIEW OF THE DEVICE HISTORY RECORD, NO NON-CONFORMANCE REPORTS GERMANE TO THE COMPLAINT CONDITION WERE GENERATED DURING THE PRODUCTION OF THESE DEVICES. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 DURING A LEFT HIP FRACTURE CASE ON (B)(6) 2017, DURING HELICAL BLADE INSERTION, THE HELICAL BLADE INSERTER WAS IMPINGED BY THE BLADE GUIDE SLEEVE DUE TO MISALIGNMENT BY THE SURGEON. THE ENTRY SURFACE OF THE BLADE GUIDE SLEEVE BECAME DEFORMED AS A RESULT. AN ALTERNATE HELICAL BLADE INSERTER AND BLADE GUIDE SLEEVE WERE AVAILABLE FOR USE AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A 90 SECOND DELAY AND NO HARM TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN HELICAL BLADE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157458 BLADE/SCREW GUIDE SLEEVE GUIDE FZX SYNTHES BETTLACH 9351397 10886982070333

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR UNKNOWN HELICAL BLADE, QUANTITY 1