BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 4222779 · Received November 4, 2014

    Report

    Report Number
    3003787298-2014-10058
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE DEVICE HISTORY RECORD FOR THE CORRECT LOT WAS REVIEWED AND THERE ARE NO NONCONFORMANCES FOUND THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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

    ADDITIONAL NARRATIVE: PATIENT IDENTIFYING INFORMATION IS NOT AVAILABLE FOR REPORTING. PRODUCT INVESTIGATION EVALUATION: TWO HELICAL BLADE INSERTERS WERE RECEIVED WITH THE COMPLAINT CATEGORY OF ¿DOES NOT/WILL NOT FUNCTION: WILL NOT TENSION/TIGHTEN.¿ THE INSERTER IS A COMPONENT OF THE TITANIUM TROCHANTERIC FIXATION NAIL (TFN) SYSTEM INTENDED FOR THE INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES AND IS SPECIFICALLY FOR THE INSERTION OF THE HELICAL BLADE. THIS INFORMATION IS PROVIDED PER TFN SYSTEM TECHNIQUE GUIDE. LOT NUMBER 6329824 WAS MANUFACTURED FEBRUARY, 2010. LOT NUMBER 6641977 WAS MANUFACTURED APRIL, 2011. BOTH SHOW SIGNIFICANT WEAR AND DAMAGE. THE GOLD HANDLES HAVE NUMEROUS HAMMER DENTS AND THE GUIDE PINS SHOW 2 WORN DOWN FLATS ON EACH PIN. BOTH ALIGNMENT INDICATORS ARE DENTED. THE ALIGNMENT INDICATOR ON THE FIRST HAS A WORN ALIGNMENT PIN AND THE PEG RESPONSIBLE FOR RETENTION IS BROKEN IN HALF. IT IS BROKEN SUCH THAT THE THREADED HALF REMAINS IN THE DEVICE AND THE OTHER HALF WAS NOT RETURNED. THE WELD ON THE POST CAP IS ALSO BROKEN. IN THIS CONDITION, THE ALIGNMENT INDICATOR IS NOT RETAINED ON THE REMAINDER OF THE DEVICE AND SPINS FREELY. THUS, THE COMPLAINT CONDITIONS ARE CONFIRMED AND COULD BE REPLICATED AS THE ALIGNMENT INDICATORS ARE NOT PROPERLY RETAINED. THE DEVICES WERE MANUFACTURED PRIOR TO THE RELEASE OF THE CURRENT DRAWING REVISION. THEREFORE, A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DRAWING REVISION AT THE TIME OF MANUFACTURE WAS PERFORMED. THE TWO DESIGN REVISIONS SINCE THE DATE OF MANUFACTURE WERE FOUND TO NOT IMPACT THE COMPLAINT. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED AND THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE. THEREFORE, THE COMPLAINT CONDITION WAS DETERMINED TO NOT BE THE RESULT OF A DESIGN DEFICIENCY. THIS DEFORMATION IS CONSISTENT WITH HAMMERING AND FORCEFUL MISALIGNMENT. THE HELICAL BLADE INSERTER IS NOT INTENDED TO BE HAMMERED ON OR TO BE USED IN IMPLANT REMOVAL BUT THE HAMMER DENTS IN BOTH THE DIRECTION OF INSERTION AND REMOVAL SHOW SIGNS THAT HAMMERING WAS USED. THE FLATS ON THE GUIDE PINS SHOW EVIDENCE OF FORCEFUL MISALIGNMENT BECAUSE THERE IS ONLY ONE CORRECT ALIGNMENT OF THE HELICAL BLADE INSERTER INTO THE BLADE GUIDE SLEEVE SUCH THAT THE GUIDE PINS WILL MATE WITH THE GROOVES ON THE BLADE GUIDE SLEEVE. THIS LIKELY CAUSED THE DAMAGE THAT RESULTED IN THE RETENTION ISSUES OF THE ALIGNMENT INDICATOR. ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED WITHOUT ADDITIONAL INFORMATION REGARDING THE USER TECHNIQUE AND THE CONDITION AT THE TIME OF THE DAMAGE, THE MOST PROBABLE CAUSE OF THE COMPLAINT CONDITION IS THE METHOD OF USE. THE COMPLAINT CONDITION IS CONFIRMED AS THE ALIGNMENT INDICATORS ARE NOT PROPERLY RETAINED DUE TO DAMAGE OF THE DEVICE. THE COMPLAINT CONDITION WAS DETERMINED TO NOT BE THE RESULT OF ANY DESIGN DEFICIENCIES. DEVICE 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND REWORK WAS FOUND ON PART NUMBER (B)(4), LOT 6443058 FOR RESIDUE ON THE INSIDE DIAMETER. THE PARTS WERE CLEANED, INSPECTED AND ACCEPTED. REWORK WAS FOUND ON PART NUMBER (B)(4), LOT 6446197 FOR RESIDUE ON THE INSIDE DIAMETER. THE PARTS WERE CLEANED, INSPECTED AND ACCEPTED. THE REWORKS FOUND ARE NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS VISUAL. NO ISSUE WAS FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A PROBLEM TIGHTENING AND LOOSENING N55 ON TWO HELICAL BLADE INSERTERS. THE LOCKING NUT BACKS ALL THE WAY OUT ON OCCASION. THE INSTRUMENT IS STILL FUNCTIONAL; HOWEVER THERE IS CONCERN BY THE HOSPITAL THAT IT WILL FAIL DURING A SURGERY. THERE WAS A SIMILAR/LIKE INSTRUMENTS WERE AVAILABLE TO USE. THERE WAS NO REPORTED DELAY TO ANY PROCEDURE. THE CONDITION OF THE PATIENT AFTER SURGERY WAS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706572 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 6329824

    Patients

    Seq Age Sex Outcome Treatment
    1