BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTER-EXTRACTOR FOR TI TIBIAL & HUMERAL NAILS

    MDR report key: 5973940 · Received September 23, 2016

    Report

    Report Number
    2530088-2016-10257
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DHR REVIEW FOR PART# 356.49 LOT# A4HV010, RELEASE TO WAREHOUSE DATE: 11FEB1999, MANUFACTURED BY SYNTHES (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE FOLLOWING SUBJECT DEVICES: ONE 4.5MM PIN WRENCH 120MM (PART NUMBER: 321.17, LOT NUMBER: 2239190), ONE SLOTTED HAMMER (PART NUMBER: 332.20, LOT NUMBER: 5139), ONE INSERTER-EXTRACTOR FOR TI TIBIAL AND HUMERAL NAILS (PART NUMBER: 356.49, LOT NUMBER: A4HV010), ONE EXTRACTION SCREW FOR TITANIUM TIBIAL NAIL (PART NUMBER: 356.543, LOT NUMBER: 4650979) THE COMPLAINT CONDITION IS CONFIRMED FOR ALL PARTS. A VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. PLEASE NOTE ONE 11MM TI CANNULATED TIBIAL NAIL (PART NUMBER: 485.134S, LOT NUMBER: 4030761, MFG DATE: 08FEB2000) WAS ALSO RECEIVED, HOWEVER AS PER THE COMPLAINT DESCRIPTION THE IMPLANT DID NOT CONTRIBUTE TO THE COMPLAINT DESCRIPTION AS THE NAIL WAS BEING REMOVED AS PREPARATION FOR AN UPCOMING TOTAL KNEW REPLACEMENT FOR THE PATIENT. THEREFORE NO FURTHER INVESTIGATION IS NEEDED, INCLUDING A RISK ASSESSMENT. THE RETURNED INSTRUMENTS ARE INSTRUMENTS ROUTINELY USED DURING THE REMOVAL OF TIBIAL NAILS IN THE TITANIUM TIBIAL NAIL SYSTEM. PART 1 (PIN WRENCH) WAS RECEIVED WITH A NOTICEABLE BENDING ALONG THE SHAFT OF THE DEVICE. PART 2 (SLOTTED HAMMER) WAS RECEIVED WITH THE SLOTTED PORTION ALL PITTED UP AND THE SHAFT NOTICEABLE BENT. PART 3 (INSERTER-EXTRACTOR) WAS RECEIVED WITH DAMAGE THROUGH THE LENGTH OF THE DEVICE. PART 4 (EXTRACTION SCREW) WAS RECEIVED STUCK ONTO THE CANNULATED TIBIAL NAIL AND CANNOT BE REMOVED. THE COMPLAINT CONDITION FOR ALL INSTRUMENTS WAS CONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED DEVICES WERE REVIEWED:. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES AT THE TIME OF THE EVENT ARE UNKNOWN. IT MAY BE DUE TO THE IMPLANTED BEING EMBEDDED IN THE PATIENT FOR 16+ YEARS AND THE BONY INGROWTH THAT RESULTED IN THE IMPLANT BECOMING HARDENED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ORIGINALLY IMPLANTED WITH A NAIL TO REPAIR A RIGHT TIBIA FRACTURE ON AN UNKNOWN DATE IN 2000. ON (B)(6) 2016, THE SURGEON EXPERIENCED DIFFICULTY WHILE ATTEMPTING TO BACK OUT THE NAIL DURING A TIBIAL NAIL REMOVAL. THE REMOVAL WAS PERFORMED IN PREPARATION FOR AN UPCOMING TOTAL KNEE REPLACEMENT. BONY INGROWTH WAS PRESENT IN THE DYNAMIC LOCKING HOLE IN THE PROXIMAL PORTION OF THE NAIL. THE NAIL REMOVAL REQUIRED THE USE OF OSTEOTOMES, IMPACTORS AND BRUTE FORCE. A PIN WRENCH, A SLOTTED HAMMER, AN INSERTER-EXTRACTOR FOR TIBIAL NAILS AND AN EXTRACTION SCREW BECAME BENT DURING THE REMOVAL PROCESS. THE EXTRACTION BOLT REMAINS JAMMED INTO THE NAIL. THERE WAS A REPORTED 90-120 MINUTE SURGICAL DELAY. THE NAIL AND FOUR (4) 4.9MM LOCKING BOLTS WERE REMOVED FULLY INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: CANNULATED TIBIAL NAIL (PART #485.134, LOT #4030761, QUANTITY 1), 4.9MM LOCKING BOLTS (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 4). THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624753 INSERTER-EXTRACTOR FOR TI TIBIAL & HUMERAL NAILS EXTRACTOR HWB SYNTHES BRANDYWINE A4HV010

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention (PART #485.134, LOT #4030761, QUANTITY 1)| (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY 4)