BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3881127 · Received June 18, 2014

    Report

    Report Number
    2520274-2014-11975
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 22, 2014
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: THE DHR WAS REVIEWED AND REWORK WAS FOUND ON P/N 357.372 LOT #7394650 FOR BLACK RESIDUE IN INSIDE DIAMETER OF 357.372.1 GUIDE SHAFT. ALL NONCONFORMING PARTS WERE CLEANED, INSPECTED AND PASSED. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION BECAUSE THE ISSUE IS VISUAL. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. A PRODUCT EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES INDICATES THAT: THE HELICAL BLADE INSERTER (357.372 LOT 7394650) IS A COMPONENT OF THE TROCHANTERIC FIXATION NAIL (TFN) LOCKING SET (690.340) WHICH IS USED FOR INTRAMEDULLARY FIXATION OF PROXIMAL FEMUR FRACTURES. THE HELICAL BLADE INSERTER IS UTILIZED TO INSERT 11.0 MM HELICAL BLADES WHICH ARE USED TO PROXIMALLY SECURE A NAIL. THE FOLLOWING DRAWINGS FOR THE INSERTER WERE REVIEWED: TOP LEVEL (357_372 REV E), ALIGNMENT INDICATOR (357_372_3 REV D) AND LOCKING SHAFT (357_372_3_3 REV C). THE DRAWINGS WERE FOUND SUITABLE TO DETERMINE THE INTENDED DEVICE DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY. THE 2.0MM LOCATOR PIN IS USED TO ALIGN THE ALIGNMENT INDICATOR WITH THE GUIDE SHAFT. THE LOCKING SHAFT IS DESIGNED TO BE UNSCREWED FOR DISASSEMBLY AND TIGHTENED AFTER ASSEMBLY TO SECURE THE ALIGNMENT INDICATOR TO THE GUIDE SHAFT. THE DESIGNS ARE ADEQUATE FOR THEIR INTENDED PURPOSES. THE ALIGNMENT INDICATOR IS NOT INTENDED TO BE STRUCK WITH A HAMMER; THEREFORE THE LOCATOR PIN AND LOCKING SHAFT WERE NOT DESIGNED TO BE ABLE TO WITHSTAND THE RESULTING FORCE. IN ORDER TO FULLY INSERT THE HELICAL BLADE, LIGHT HAMMER BLOWS MAY BE NECESSARY ON THE BACK OF THE COUPLING SCREW. CLEAR WITNESS MARKS ARE PRESENT ON BOTH EARS OF THE ALIGNMENT INDICATOR AND ARE CONSISTENT WITH A SHEARED OFF PIN. AN INADVERTENT BLOW TO THE INDICATOR WOULD SHEAR OFF THE LOCATOR PIN, WHICH WOULD ALLOW THE INDICATOR TO SPIN FREELY. ADDITIONALLY CLEAR WITNESS MARKS ARE PRESENT ON THE LOCKING SHAFT. A DIRECT BLOW TO THE HEAD OF THE SCREW WHILE LOOSENED WOULD BE ENOUGH TO CAUSE THE SCREW TO FRACTURE AT THE COMPONENT¿S WEAK POINT. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INSTRUMENT DID BREAK SO THE COMPLAINT IS CONFIRMED. THIS COMPLAINT CONDITION IS THE RESULT OF REPEATED HAMMERING AND A CUMULATIVE SUM OF MULTIPLE MISS-STUCK HAMMER BLOWS TO THE ALIGNMENT INDICATOR AND SPECIFICALLY ONE DIRECT BLOW TO THE LOCKING SHAFT. NEITHER COMPONENT IS INTENDED TO RECEIVE HAMMER BLOWS AND THEY WERE NOT DESIGNED TO WITHSTAND SUCH BLOWS. THE RETURNED CONDITION OF THE DEVICE REVEALS THAT THE METHOD OF USE RATHER THAN ANY DESIGN DEFICIENCY HAS RESULTED IN THIS CONFIRMED COMPLAINT. THE DEVICE IS DETERMINED SUITABLE FOR ITS INTENDED AND RECOMMENDED USE. 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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.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

    DATE OF EVENT: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HELICAL BLADE INSERTER WAS DISCOVERED BROKEN IN STERILE PROCESSING. IT WAS REPORTED THAT THE HEAD HAD COME OFF THE SET SCREW. THE EVENT IS NOT RELATED TO ANY SPECIFIC PATIENT OR CASE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358528 HELICAL BLADE INSERTER MISC ORTHO SURGICAL INSTR LXH SYNTHES JENNERSVILLE 7394650

    Patients

    Seq Age Sex Outcome Treatment
    1