BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

    MDR report key: 6149041 · Received December 6, 2016

    Report

    Report Number
    1719045-2016-10884
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 11, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.404, LOT# U210481. SUPPLIER: (B)(6), RELEASE TO WAREHOUSE DATE: (B)(6) 2014. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED FOR PART# 03.010.404, LOT# U210481. ONE (1) CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSTRUMENTS FOR NAILS-EXPERT WAS RETURNED FOR MANUFACTURING EVALUATION/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. AS PER THE TECHNIQUE GUIDE, THE RETURNED DEVICES ARE USED TOGETHER FOR TARGETED PROXIMAL LOCKING OF THE TITANIUM CANNULATED TIBIAL ¿ EX NAILS WHEN A SUPRAPATELLAR APPROACH IS DESIRED. THE DEVICES WERE EACH RECEIVED INTACT. THE DISTAL THREADS OF THE CONNECTING SCREW SHOW WORN EDGES AND SMALL INDENTS WERE OBSERVED ON THE PROXIMAL END OF THE PROTECTION SLEEVE. THE BALANCE OF EACH DEVICE SHOWS WEAR CONSISTENT WITH USE. WHEN TESTED WITH A FUNCTIONAL NAIL (PART 04.034.555S / LOT H161903) THE DEVICES WERE EACH FOUND TO FUNCTION AND INTENDED AND FORM A FUNCTIONAL CONSTRUCT. THE DEVICES COULD SUBSEQUENTLY BE DISASSEMBLED AS INTENDED. THUS, AS NO FUNCTIONAL ISSUE WAS IDENTIFIED, THE COMPLAINT CONDITION IS UNCONFIRMED AND COULD NOT BE REPLICATED. A REVIEW OF APPROPRIATE DESIGN DRAWINGS (CURRENT/MANUFACTURED REVISION) WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. IN CONCLUSION, THE DEVICES WERE FOUND TO BE IN GOOD FUNCTIONING CONDITION AND DID NOT EXHIBIT ANY UNSPECIFIED FUNCTIONAL ISSUES. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE RECEIVED DEVICES WERE FOUND TO FUNCTION AS INTENDED. 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) 2016 PATIENT UNDERWENT SUPRAPATELLAR TIBIAL NAILING PROCEDURE. DURING THE PROCEDURE WHILE DRILLING TO PLACE THE PROXIMAL SCREW, THE DRILL BIT HIT THE NAIL. THE DRILL BIT DID NOT BREAK. THE SURGEON WAS ABLE TO REPOSITION THE DRILL GUIDE, DRILL THE HOLE AND PLACE THE PROXIMAL SCREW SUCCESSFULLY. AFTER THE NAIL AND SCREW WERE SUCCESSFULLY IMPLANTED, AN ANTICIPATED X-RAY FILMS WERE TAKEN TO CONFIRM PLACEMENT OF THE NAIL. WHILE REMOVING THE HE INSERTION INSTRUMENTS FROM THE NAIL, IT WAS NOTED THAT THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, PROTECTION SLEEVE AND OUTER DRILL SLEEVES WERE VERY DIFFICULT TO REMOVE FROM THE NAIL AND SEEMED TO BE STUCK. SURGEON HAD TO FORCEABLY REMOVE THE INSTRUMENTS FROM THE NAIL AND CAUSED A 15-20 MINUTE PROCEDURAL DELAY TO REMOVE THEM. THE PATIENT WAS STABLE DURING AND FOLLOWING THE SURGERY. THERE WERE NO REPORTED FRAGMENTS GENERATED AND NO HARM TO THE PATIENT WAS REPORTED. CONCOMITANT DEVICES REPORTED: DRILL GUIDE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY: 1). DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW F/PERCUTANEOUS INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799075 CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX GUIDE FZX SYNTHES MONUMENT U210481

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE (1) UNKNOWN DRILL BIT| ONE (1) UNKNOWN DRILL GUIDE