BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7207267 · Received January 19, 2018

    Report

    Report Number
    2939274-2018-50335
    Event Type
    Malfunction
    Date Received
    January 19, 2018
    Date of Event
    January 1, 2017
    Report Date
    December 26, 2017
    Manufacturer
    WRIGHTS LANE : SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068941
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. UNKNOWN DATE IN 2017. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). 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.

    Additional Manufacturer Narrative · 1

    DATE PREVIOUSLY REPORTED IN (B)(4) WAS 2/9/2017. CORRECT DATE SHOULD HAVE BEEN REPORTED AS 2/9/2018 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

    DHR REVIEW WAS COMPLETED. PART NO.: 03.010.473, LOT NO.: 8012995, MANUFACTURING LOCATION: (B)(4). RELEASE TO WAREHOUSE DATE: 30.JUL.2012 . NO NCRS 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. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. THE SCREW DRIVER (PART: 03.010.473, LOT: 8012995, MFG: 03-JUL-2012) WAS RECEIVED WITH THE REPORTED CONDITION OF STRIPPED/WORN/TWISTED/CROSS THREADED: RM THE DEVICE WAS INITIALLY RECEIVED AT SERVICE AND REPAIR. THE CUSTOMER REPORTED THE TIP OF THE SCREWDRIVER WAS TWISTED. THE REPAIR TECHNICIAN REPORTED THE TIP OF THE DRIVER WAS BENT AND TWISTED, AND THE DRIVER WAS NON-FUNCTIONAL. BENT 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. THE RETURNED SCREW DRIVER (PART: 03.010.473, LOT: 8012995, MFG: 03-JUL-2012) WAS INSPECTED AT CUSTOMER QUALITY AND THE COMPLAINT OF TWISTED TIP WAS CONFIRMED. THE RETURNED DEVICE WAS EXAMINED AND THE DISTAL TIP OF THE MAIN DRIVER SHAFT IS OBSERVED TO BE TWISTED IN THE DIRECTION OF RESISTANCE PROVIDED DURING SCREW INSERTION. ADDITIONALLY, THE DISTAL TIP OF THE SLIDER BAR WAS OBSERVED TO BE SLIGHTLY TWISTED. THE NUT COMPONENT WAS RETURNED. NO NEW MALFUNCTIONS HAVE BEEN IDENTIFIED. THE COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO THE POST-MANUFACTURING DAMAGE. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL, SHAFT, AND SLIDING BAR, THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. A DEVICE HISTORY REVIEW, INCLUDING MATERIAL AND HARDNESS REVIEWS, WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO NCRS, MRRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES SUCH AS EXCESSIVE TWISTING DURING USAGE OR IMPROPER ALIGNMENT AND SCREWING OF DRIVER SHAFTS INTO THE NUT PRIOR TO THE DEVICE USAGE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 TIP OF SCREWDRIVER WAS TWISTED AND IT DOESN'T RETAIN THE SCREW. THE EVENT WAS FOUND DURING THE STERILE PROCESSING. NO PATIENT OR PROCEDURE INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50661 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 8012995 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1