BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR

    MDR report key: 4100736 · Received September 19, 2014

    Report

    Report Number
    3003875359-2014-10274
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HSB
    PMA / PMN Number
    PK092646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: HWC. 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 NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE TFN INSERTER/EXTRACTOR IS USED TO ASSIST IN THE INSERTION AND EXTRACTION OF SCREWS WHICH ARE DESIGNED TO HELP SECURE IMPLANTS. DRAWING (B)(4)) WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IT IS MOSTLY LIKELY THAT THE SUBJECT COMPLAINT WAS CAUSED BY AN OVER-INSERTION OF A LAG SCREW, WHICH SUBSEQUENTLY LED TO OVER TORQUING AND THE DAMAGE TO THE TANGS AT THE TIP OF THE INSERTER/EXTRACTOR WHICH INTERACTS WITH LAG SCREWS. FROM (B)(4) 2008 TO (B)(4) 2014, THERE HAVE BEEN A TOTAL OF (B)(4) RELEVANT GLOBAL COMPLAINTS INVOLVING 357.428. DURING THE SAME TIME PERIOD THERE WERE A TOTAL OF 47,823 11MM LAG SCREWS SOLD GLOBALLY. THE TFN INSERTER/EXTRACTOR IS USED WITH THE INSERTION AND EXTRACTION OF 11MM LAG SCREWS, THEREFORE THEY MUST BE CONSIDERED WHEN CALCULATING OCCURRENCE RATE BASED ON THE INVESTIGATION OF THE RETURNED PART AND THE INFO PROVIDED WITH THE COMPLAINT, IT IS MOST LIKELY THAT THE COMPLAINT CONDITION OCCURRED DUE TO AN OVER-INSERTION OF A LAG SCREW, WHICH SUBSEQUENTLY LED TO OVER TORQUING AND THE DAMAGE TO THE TANGS AT THE TIP OF THE INSERTER/EXTRACTOR WHICH INTERACTS WITH THE SCREW. THE COMPLIANT CONDITION WAS CONFIRMED. 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 DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE, A LAG SCREW WAS INSERTED, AND HANDLE WAS REMOVED. X-RAY SHOWED THE SCREW WAS NOT IN THE RIGHT LOCATION. SURGEON TRIED TO USE THE TFN SCREW INSERTER/EXTRACTOR TO RE-ENGAGE SCREW, AT WHICH POINT THE TROCHANTERIC FIXATION NAIL (TFN) SCREW INSERTER/EXTRACTOR BENT. THE INSERTER/EXTRACTOR WAS REMOVED FROM THE SLEEVE. WITH THE SLEEVE REMOVED, THE INSERTER/EXTRACTOR COULD BE USED TO COMPLETE THE PROCEDURE. THERE WAS A 15 MINUTE DELAY AND NO PATIENT HARM. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581835 TROCHANTERIC FIXATION NAIL SCREW INSERTER/EXTRACTOR ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES HAGENDORF 3562968

    Patients

    Seq Age Sex Outcome Treatment
    1