BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3091582 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02281
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE DHR WAS REVIEWED AND MRR 36961 WAS FOUND ON RAW MATERIAL P/N 11036 LOT 4426211 FOR SURFACE ROUGHNESS NOT ON THE SUPPLIER CERTIFICATE OF CONFORMANCE. THE SUPPLIER PROVIDED THE REVISED CERTIFICATE AND IT WAS REVIEWED AND ACCEPTED BY THE QE. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT CONDITION BECAUSE IT FOR A DOCUMENTATION ISSUE ON RAW MATERIAL. NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RETURNED HELICAL BLADE COUPLING WAS MANUFACTURED IN MAY 2003 AND IS OVER 10 YEARS OLD AND SHOWS SIGNIFICANT WEAR AND DAMAGE. THE LOCATOR PIN HAS SHEARED OFF. THE ALIGNMENT INDICATOR SPINS FREELY ABOUT THE HANDLE. THE DESIGN WAS REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITION IS CAUSED WHEN THE HAMMER INADVERTENTLY MISSES THE HEAD OF THE COUPLING SCREW, AND HITS THE EARS OF THE INDICATOR. THIS MAY CAUSE THE PIN IN THE INDICATOR TO BE DAMAGED AND THEREFORE THE INDICATOR MAY SPIN FREELY OR IT MAY BECOME JAMMED. FOR THIS PRODUCT COMPLAINT, THE INDICATOR SPINS FREELY. THE PRIMARY PURPOSE OF THE INDICATOR IS TO CAPTURE THE GOLD HANDLE ON THE INSERTER. IF THE TOP SPINS FREELY OR BECOMES JAMMED, IT IS STILL HELD IN PLACE AND DOES NOT FALL OFF OF THE HELICAL BLADE INSERTER AND THEREFORE THE CASE CAN BE COMPLETED WITHOUT INCIDENT. THERE ARE NUMEROUS DENTS ON THE ALIGNMENT INDICATOR AND THE KNURLED SURFACE OF THE THUMB SET SCREW, THAT HAS SHEARED OFF AND WAS RETURNED IN A SEPARATE BAG, INDICATING THAT IT HAS BEEN STRUCK WITH THE MALLET DURING USE AND THE PIN IS DAMAGED. THE TROCHANTERIC FIXATION NAIL RISK ASSESSMENT ADEQUATELY ADDRESSES THIS COMPLAINT CONDITION. SPECIFICALLY, THE 12TH HAZARD UNDER LINE ITEM BLADE INSERTION TOOL AND COUPLING SCREW ASSESSES THE RISK ASSOCIATED WITH INDICATOR TOP OF BLADE INSERTER EITHER BEING JAMMED OR FREELY SPINNING DUE TO SURGEON HAMMERRING ON THE EARS OF THE INDICATOR INSTEAD OF THE COUPLING SCREW HEAD AS A LESS SEVERE WITH A MARGINAL SEVERITY OF HARM 2 AND AN UNLIKELY PROBABILITY OF OCCURRENCE 2. THE DESIGN WAS REVIEWED AND DETERMINED TO BE ACCEPTABLE FOR THE INTENDED USE FOR THE RETURNED PART. THIS COMPLAINT CONDITION FOR THE INSERTER IS CAUSED BY INADVERTENT HAMMER BLOWS, NOT THE DEVICE DESIGN. PLACEHOLDER.

    Description of Event or Problem · 1

    DURING A TROCHANTERIC FIXATION NAIL SYSTEM (TFN) PLACEMENT ON AN UNKNOWN DATE, THE WINGED PIECE WITH SET SCREWS THAT ATTACHES TO THE HELICAL BLADE WAS DISASSEMBLED. THE ITEM WAS PUT BACK TOGETHER BUT WAS LOOSE. THIS OCCURRED A COUPLE TIMES DURING THE PROCEDURE. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT IMPACT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194250 HELICAL BLADE INSERTER LXH SYNTHES USA 4589447

    Patients

    Seq Age Sex Outcome Treatment
    1