BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7361348 · Received March 22, 2018

    Report

    Report Number
    2939274-2018-51153
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Report Date
    February 22, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982068934
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART: 03.010.472, LOT: 8111450, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: (B)(6) 2012. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: IT WAS REPORTED THAT AN INTERLOCK SCREWDRIVER IS STRIPPED. THE CUSTOMER REPORTED THE INTERLOCK SCREWDRIVER WAS STRIPPED. THE REPAIR TECHNICIAN REPORTED THE TIP OF THE SCREWDRIVER WAS TWISTED. 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 SCREWDRIVER WAS FOUND TO BE BENT, STRIPPED AND TWISTED. THE DISTAL TIP OF THE STARDRIVE FEATURE IS BENT DISTALLY, ADDITIONALLY THE TIP WAS TWISTED IN THE DIRECTION OF SCREW INSERTION. THE TIP IS ALSO STRIPPED/WORN DOWN. THE SLIDING BAR DOES NOT ENGAGE WITH THE SHAFT PROPERLY. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BENT AND TWISTED. DRAWINGS WERE REVIEWED DURING INVESTIGATION. DIMENSIONAL INSPECTION OF THE TIP WAS NOT CONDUCTED DUE TO THE POST MANUFACTURING DEFORMATION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED; HOWEVER, IT IS LIKELY THAT THE DEVICE EXPERIENCED EXCESSIVE FORCE DURING SCREW INSERTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. DATE OF EVENT: UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 THE INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM IS STRIPPED. NO REPORTED PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205140 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 8111450 10886982068934

    Patients

    Seq Age Sex Outcome Treatment
    1