BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

    MDR report key: 5409929 · Received February 4, 2016

    Report

    Report Number
    1719045-2016-10110
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    January 11, 2016
    Report Date
    January 11, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSTRUMENT FOR NAILS-EX (PRODUCT CODE: 03.010.404, LOT NUMBER: U133696), WAS RECEIVED UNDAMAGED. THERE WAS NO OBSERVABLE DAMAGE OR ISSUES FOUND WITH THE DEVICE. THE DISTAL THREADS OF THE DEVICE WERE UNDAMAGED. THERE WAS COSMETIC DAMAGE ON THE EXTERIOR BODY OF THE DEVICE THAT WOULD NOT HAVE IMPACTED THE FUNCTION OF THE DEVICE. THE COMPLAINT CONDITION COULD NOT BE REPLICATED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: APRIL 07, 2011. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT TIBIA ON (B)(6) 2016, WHEN ATTEMPTING TO DISENGAGE THE CONNECTING SCREW FROM THE NAIL THE SURGEON MET RESISTANCE. AFTER A DELAY OF FIFTEEN (15) MINUTES, THE SURGEON REMOVED ALL SCREWS AND BACKED OUT THE NAIL. THE CONNECTING SCREW FINALLY RELEASED FROM THE NAIL, BUT IT WAS NOTICED THE TOP OF THE NAIL WAS BROKEN AT THE HEAD. ANOTHER LENGTH NAIL WAS ATTEMPTED, TWO PROXIMAL SCREWS WERE INSERTED AND ATTEMPTED TO DISENGAGE THE SAME CONNECTING SCREW ONCE MORE AND MET RESISTANCE A SECOND TIME. THE SURGEON REMOVED ALL SCREWS AND REMOVED THE CONNECTING SCREW COMPLETELY. THE SURGEON DECIDED TO UTILIZE A NON-SYNTHES DEVICE INSTEAD. THERE WAS A THIRTY TO FORTY-FIVE (30-45) MINUTE SURGICAL DELAY DUE TO THE ISSUE WITH THE CONNECTION SCREW. IT WAS ALSO REPORTED THAT DURING THIS PROCEDURE WHEN THE SURGEON WAS PUTTING THE DRILL BIT THROUGH THE TROCAR THE SURGEON MET RESISTANCE WITH THE NAILS. THERE IS A CONCERN THAT THE AIMING ARM MAY NOT BE CALIBRATED CORRECTLY. THE CONSTRUCT WAS ASSEMBLED PROPERLY. BECAUSE THE CONNECTING SCREW WAS NOT FUNCTIONING PROPERLY THIS MAY HAVE CONTRIBUTED TO THE MISALIGNMENT OF THE DEVICES. THIS IS REPORT 3 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69134 CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX GUIDE FZX SYNTHES MONUMENT U133696

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention