BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    MDR report key: 6365227 · Received February 28, 2017

    Report

    Report Number
    3003875359-2017-10087
    Event Type
    Malfunction
    Date Received
    February 28, 2017
    Date of Event
    January 6, 2017
    Report Date
    January 6, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 03.010.473 WITH LOT NUMBER(S) 8012995 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS AUGUST 06, 2012. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JULY 30, 2012. 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 CUSTOMER REPORTED THE SCREWDRIVER WOULD NOT HOLD THE SCREW. THE REPAIR TECHNICIAN REPORTED THE TIP WAS DAMAGED. DAMAGED COMPONENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLAINT WAS ABLE TO BE CONFIRMED AT CUSTOMER QUALITY AS THE INTERLOCKING SCREWDRIVER WAS RECEIVED WITH THE DISTAL TIP OF THE MAIN BODY TWISTED AND DEFORMED. IN ADDITION, ONE OF THE PRONGS OF THE DISTAL TIP HAD SHEARED OFF. THIS FRAGMENT WAS NOT RETURNED WITH THE COMPLAINT. A VISUAL INSPECTION, DEVICE HISTORY REVIEW (DHR), SERVICE HISTORY AND EVALUATION, AND DRAWING REVIEW, WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. THIS INTER-LOCK SCREWDRIVER IS INTENDED FOR INSERTION AND REMOVAL OF DISTAL LOCKING SCREWS DURING FEMORAL AND TIBIAL NAIL PROCEDURES. THE TITANIUM CANNULATED TIBIAL NAILS TECHNIQUE GUIDE AND THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL TECHNIQUE GUIDE WERE REVIEWED DURING THE INVESTIGATION AND FOUND TO ADDRESS RECOMMENDED USAGE. THE RELEVANT PRODUCT DRAWING WAS REVIEWED DURING THE INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. ALTHOUGH THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THE DAMAGE IS CONSISTENT WITH EXCESSIVE ADVANCEMENT OF THE SLIDING MECHANISM AS THE TIP OF THE SCREWDRIVER IS COMPRESSED, MOST LIKELY IN THE SCREW HEAD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTER-LOCK SCREWDRIVER DID NOT HOLD A SCREW. ON (B)(6) 2017 A PATIENT UNDERWENT INITIAL IMPLANT SURGERY WITH A RETROGRADE FEMORAL NAIL TO TREAT A FEMUR FRACTURE. AS THE SURGEON ATTEMPTED TO IMPLANT A PROXIMAL SCREW, THE INTER-LOCK SCREWDRIVER DID NOT HOLD THE SCREW. ANOTHER SCREWDRIVER WAS AVAILABLE FOR USE AND THE SAME PROXIMAL SCREW WAS IMPLANTED WITHOUT DIFFICULTY. THERE WAS A FIVE MINUTE SURGICAL DELAY. THERE WAS NO PATIENT HARM AND THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS STABLE. UPON RECEIVING THE DEVICE AT THE MANUFACTURER, IT WAS NOTICED A PRONG WAS BROKEN OFF FROM THE HEAD OF THE SCREWDRIVER. CONCOMITANT DEVICE: PROXIMAL SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149252 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX SYNTHES HAGENDORF 8012995 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR ONE UNKNOWN PROXIMAL SCREW