BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELICAL BLADE INSERTER

    MDR report key: 3223432 · Received July 12, 2013

    Report

    Report Number
    2530088-2013-01002
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THERE WERE MINOR IMPACT MARKS ON GOLD HANDLE OF HELICAL BLADE INSERTER. ALIGNMENT INDICATOR POSTS SHOW SIGNS OF IMPACT AS WELL. PIN IN THE ALIGNMENT INDICATOR DAMAGED TO THE POINT WHERE THE ALIGNMENT INDICATOR CANNOT MATE TO THE SHAFT OF THE HELICAL BLADE INSERTER. THIS PRODUCT WAS SOLD IN FEBRUARY 2006. A NEW HELICAL BLADE WAS ABLE TO BE MATED TO THE INSERTER WITH NO PROBLEMS. THE THIN PIECE OF METAL IS IN REFERENCE TO THE ALIGNMENT PIN IN THE ALIGNMENT INDICATOR PORTION OF THE INSERTER, WHICH HAS NO EFFECT ON THE TARGETING OF THE PROXIMAL HOLE OF THE NAIL. THERE ARE MANY POTENTIAL FACTORS THAT COULD LEAD TO A MISTARGET OF THE PROXIMAL HOLE SUCH AS: EXCESSIVE SOFT TISSUES FORCES ACTING ON THE PROTECTION SLEEVES, NOT FOLLOWING THE TECHNIQUE, OVER TIGHTENING OF THE CONNECTING SCREW CAUSING THE CONSTRUCT TO ROTATE, ETC. THE DESIGN RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND MRR WAS FOUND ON P/N 357.372.1.1 LOT #5067890 FOR MACHINE LINES ON 2 OUT OF 16 SUPPLIER PARTS. THE 2 NONCONFORMING PARTS WERE SCRAPPED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT CONDITION BECAUSE THE ISSUE IS VISUAL AND WOULD NOT CONTRIBUTE TO THE COMPLAINT ISSUE. MRR WAS FOUND ON P/N 357.372.2 LOT #5049309 FOR NICK ON THE END OF THE PART ON (B)(4) OUT OF (B)(4) SUPPLIER PARTS. ALL PARTS IN THE LOT WERE REWORKED, INSPECTED AND PASSED. THIS NONCONFORMANCE IS NOT RELEVANT TO THIS COMPLAINT BECAUSE THE ISSUE IS VISUAL AND WOULD NOT CONTRIBUTE TO THE COMPLAINT ISSUE.

    Description of Event or Problem · 1

    DURING A TFN PROCEDURE ON (B)(6) 2013, WHILE INSERTING THE HELICAL BLADE, IT WAS REPORTED THE HELICAL BLADE WAS NOT ADVANCING THROUGH THE HOLE IN THE NAIL. REPORTEDLY THE SURGEON WAS ABLE TO REACH THE APPROPRIATE DEPTH AND IMPLANTATION WAS COMPLETED. THE SURGEON BELIEVES THE ISSUE WAS WITH A SMALL, THIN PIECE OF METAL ON THE HELICAL BLADE INSERTER. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324382 HELICAL BLADE INSERTER LXH SYNTHES BRANDYWINE 5122292

    Patients

    Seq Age Sex Outcome Treatment
    1