BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 4081964 · Received September 11, 2014

    Report

    Report Number
    3003875359-2014-10261
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE IS NOT A DHR AVAILABLE AS DEVICE IS OLDER THAN 12 YEARS. ACCORDING TO (B)(4) THE DOCUMENTS FOR INSTRUMENTS HAVE TO BE STORED FOR 10 YEARS. 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.

    Additional Manufacturer Narrative · 1

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RETURNED INSERTER, LOT NUMBER 1121876, WAS MANUFACTURED MARCH, 2002 AND THE RETURNED NAIL, LOT NUMBER 6235171, WAS MANUFACTURED OCTOBER, 2009. THEY WERE RECEIVED WITH THE NAIL STUCK IN THE CANNULATION OF THE INSERTER SUCH THAT THE DISTAL TIP OF THE NAIL WAS IN THE INSERTER AND THE PROXIMAL END OF THE NAIL WAS EXTENDING OUT OF THE BACK OF THE INSERTER. THE NAIL SHOWED DEEP SCRAPES THAT HAD REMOVED PORTIONS OF THE BLUE ANODIZED LAYER AND WAS BENT APPROXIMATELY 135 DEGREES. THE INSERTER HAS HAMMER MARKS ON THE DISTAL END WHERE IMPACT FROM THE HAMMER WOULD OCCUR. THERE ARE A FEW HAMMER MARKS ON THE T-HANDLE PEGS AND SIGNIFICANT DENTS IN THE BLUE HANDLE. THERE ARE SCRAPES ON THE DISTAL END OF THE INSERTER BUT THE CHUCK IS FUNCTIONAL. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT THE CONDITION THAT RESULTED IN COMPLAINT CANNOT BE REPLICATED BECAUSE THE NAIL COULD NOT BE REMOVED FROM THE INSERTER AND THE DEVICES ARE ALREADY DAMAGED. A REVIEW OF THE CURRENT EDITION OF THE DESIGN DRAWINGS, (B)(4), AND DESIGN HISTORY SINCE THE DATE OF MANUFACTURE WAS PERFORMED. THE ELASTIC NAIL DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE AND THE DESIGN HISTORY DID NOT IMPACT THE COMPLAINT CONDITION. REGARDING THE INSERTER, PROPER CARE AND MAINTENANCE, A JAMMED CONDITION OF THE CHUCK, AND THE T-HANDLE STRENGTH ARE BEING ADDRESSED, BUT DID NOT IMPACT THIS COMPLAINT CONDITION. THE DESIGN IS OTHERWISE SUFFICIENT FOR ITS INTENDED USE. THE DISTAL TIP OF THE NAIL IS CURVED AND THEREFORE IS NOT INTENDED TO BE WITHDRAWN THOUGH THE INSERTER. THUS, THE METHOD OF USE LIKELY RESULTED IN THIS COMPLAINT CONDITION. IN CONCLUSION, THE COMPLAINT CONDITION IS CONFIRMED THAT THE INSERTER AND NAIL ARE STUCK TOGETHER. THE METHOD OF USE, OF REMOVING THE DISTAL END OF THE NAIL THOUGH THE INSERTER, RESULTED IN THE COMPLAINT CONDITION. THE RISK ANALYSIS WAS FOUND TO ADEQUATELY ADDRESS THE 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 ON (B)(6) 2014, A PATIENT UNDERWENT SURGERY DUE TO A PEDIATRIC FEMUR FRACTURE. DURING SURGERY, THE TIP OF THE TITANIUM ELASTIC NAIL WAS PULLED INSIDE OF THE INSERTER. THE NAIL WAS STUCK AND COULD NOT BE REMOVED. AN ALTERNATIVE INSTRUMENT WAS USED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY OR PATIENT HARM. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560951 INSERTER FOR TI ELASTIC NAILS MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 1121876

    Patients

    Seq Age Sex Outcome Treatment
    1