BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTER-LOCK SCREWDRIVE T25/3.5MM HEX/330MM

    MDR report key: 6106249 · Received November 16, 2016

    Report

    Report Number
    3003875359-2016-10596
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    September 11, 2016
    Report Date
    October 25, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT ID - (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. SERVICE HISTORY REVIEW WAS ATTEMPTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 03.010.472 WITH LOT NUMBER 7955817 IS A LOT/BATCH CONTROLLED ITEM. THE RELEASE TO WAREHOUSE DATE OF THIS ITEM IS 22-JUN-2012. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR PART # 03.010.472, LOT # 7955817. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUN 18, 2012. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE 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 SERVICE EVALUATION RESULTS ARE AS FOLLOWS. THE CUSTOMER REPORTED THE TIP OF THE SCREWDRIVER WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE TIP OF THE SCREWDRIVER WAS BENT AND DAMAGED. BENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE MANUFACTURER INVESTIGATION RESULTS ARE AS FOLLOWS. THE COMPLAINT CONDITION IS CONFIRMED. HOWEVER, IT DIFFERS FROM THE REPORTED CONDITION IN THAT THE DEVICE IS BENT BUT NOT BROKEN AS REPORTED. NO CRACKS OR MISSING PORTIONS WERE OBSERVED. THE DISTAL TIP OF THE MAIN BODY AND THE SLIDING BAR ARE TWISTED AXIALLY IN THE DIRECTION OF SCREW INSERTION AND SHOWS DEFORMED EDGES. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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 SURGERY FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT DISTAL FEMUR FRACTURE. AFTER THE PROCEDURE, IT WAS NOTED THAT THE TIP OF AN INTERLOCK SCREWDRIVER WAS BROKEN (BUT STILL ATTACHED -HANGING ON BY A THREAD). THERE WAS NO REPORTED IMPACT ON THE SURGERY. NO SURGICAL DELAY OR FRAGMENTS WERE CREATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: LOCKING OR CORTICAL SCREWS (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY UNKNOWN). 4.5MM BROAD 14 HOLE LCP PLATE (PART #UNKNOWN, LOT #UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) INTER-LOCK SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757318 INTER-LOCK SCREWDRIVE T25/3.5MM HEX/330MM SCREWDRIVERS HXX SYNTHES HAGENDORF 7955817

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR UNKNOWN QUANTITY OF UNKNOWN LCP PLATE| UNKNOWN QUANTITY OF UNKNOWN SCREWS