BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX

    MDR report key: 6682127 · Received June 30, 2017

    Report

    Report Number
    1719045-2017-10624
    Event Type
    Malfunction
    Date Received
    June 30, 2017
    Date of Event
    June 5, 2017
    Report Date
    June 5, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    10886982068569
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE FOLLOWING CONCOMITANT PART WAS RETURNED WITHOUT AN ALLEGATION AGAINST THEM PART #: 03.010.440 LOT #: 11-3173 QUANTITY: 1. THE SUPRAPATELLAR INSERTION HANDLE WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED ON THIS DEVICE. THE 03.010.475, LOT NUMBER 7719678, DRIVING CAP WAS RETURNED WITH A BROKEN OFF THREADED DISTAL TIP. THE TRANSVERSELY BROKEN TIP IS STUCK INSIDE THE CONCOMITANT SUPRAPATELLAR INSERTION HANDLE (PART #: 03.010.440). THIS COMPLAINT CONDITION IS POSSIBLY DUE TO CROSS-THREADING, EXCESSIVE FORCE ON THE CAP, AND/OR OFF AXIS HAMMERING, RESULTING IN THE DRIVING CAP TO BREAK. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DRIVING CAP IS ALREADY BROKEN. THE 03.010.404, LOT NUMBER U133696, CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX WAS RETURNED WITH NO DEFECTS OR MALFUNCTIONS OBSERVED. THE THREADS OF THE CONNECTING SCREW WERE NEITHER STRIPPED OR DAMAGED. THIS COMPLAINT AGAINST THE CONNECTING SCREW IS UNCONFIRMED. A VISUAL INSPECTION, DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT WAS UNABLE TO BE REPLICATED AT CUSTOMER QUALITY (CQ) SINCE THE MATING PART (NAIL) WAS NOT RETURNED. CQ INVESTIGATION PART #03.010.404 LOT #U133696, CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX . THE 03.010.404 CANNULATED CONNECTING SCREW IS AN INSTRUMENT ROUTINELY USED IN THE SUPRAPATELLAR INSTRUMENTATION FOR TITANIUM CANNULATED TIBIAL NAILS SYSTEM. THE CANNULATED CONNECTING SCREW WAS RETURNED WITH NO DEFECTS OR MALFUNCTIONS OBSERVED. THE THREADS OF THE CONNECTING SCREW WERE NEITHER STRIPPED OR DAMAGED. THIS COMPLAINT AGAINST THE CONNECTING SCREW IS UNCONFIRMED. DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THIS PART WAS MANUFACTURED APRIL 07, 2011. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ALTHOUGH THIS COMPLAINT WAS UNABLE TO BE REPLICATED AND UNCONFIRMED, IT IS POSSIBLE THIS COMPLAINT CONDITION WAS DUE TO CROSS THREADING OF THE CONNECTING SCREW WITH THE NAIL. 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

    PATIENT¿S DATE OF BIRTH, GENDER AND WEIGHT ARE UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER PHONE NUMBER IS UNKNOWN. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 03.010.404, SYNTHES LOT#U133696: RELEASE TO WAREHOUSE DATE: 07-APR-2011, EXPIRATION DATE: N/A, SUPPLIER: ORCHID UNIQUE: NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 A DRIVING CAP AND A CONNECTING SCREW MALFUNCTIONED DURING A TIBIA FRACTURE REPAIR ON (B)(6) 2017. THE DRIVING CAP SNAPPED OFF AT THE THREADS AND BROKE. THE THREADS ARE STUCK INSIDE OF AN INSERTION HANDLE. ALSO, A CONNECTING SCREW WAS DIFFICULT TO DISENGAGE FROM THE NAIL. THERE WAS NO REPORTED SURGICAL DELAY AND NO FRAGMENTS INVOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES: INSERTION HANDLE FOR SUPRAPATELLAR (PART # 03.010.440, LOT # 11-3173, QUANTITY: 1), NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR ONE (1) CONNECTING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461558 CANN CONNECTING SCR F/PERCUTANINSTRUMENTS FOR NAILS-EX GUIDE FZX SYNTHES MONUMENT U133696 10886982068569

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR