BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7518224 · Received May 16, 2018

    Report

    Report Number
    2939274-2018-52197
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Report Date
    March 20, 2018
    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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. UNKNOWN WHEN DEVICE MALFUNCTIONED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NO: 03.010.473, LOT NO: 9171677: MANUFACTURING LOCATION: HAEGENDORF, RELEASE TO WAREHOUSE DATE: 26.JUN.2015: NO NON-CONFORMANCE REPORTS (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. A PRODUCT INVESTIGATION WAS PERFORMED. THE INTER-LOCK SCREW DRIVER (PART: 03.010.473, LOT: 9171677, MFG: 26-JUN-2015) WAS RECEIVED WITH THE REPORTED CONDITION OF VISUAL BENT/DEFORMED. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE SLIDING PIECE WAS BENT PREVENTING THE PIECE FROM LOCKING. THE REPAIR TECHNICIAN REPORTED THE TIP ON THE DEVICE AND ATTACHMENT WERE BENT. 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: 9171677, MFG: 26-JUN-2015) WAS INSPECTED AT CUSTOMER QUALITY AND THE COMPLAINT WAS CONFIRMED. THE RETURNED DEVICE WAS VISUALLY INSPECTED AT CUSTOMER QUALITY AND THE DISTAL TIP OF THE SLIDER BAR WAS OBSERVED TO BE SLIGHTLY BENT. ADDITIONALLY, THE DISTAL TIP OF THE MAIN DRIVER SHAFT WAS OBSERVED TO BE SIGNIFICANTLY TWISTED IN THE DIRECTION OF RESISTANCE PROVIDED DURING SCREW INSERTION. THE NUT COMPONENT WAS RETURNED. THE BENT COMPLAINT CONDITION WAS UNABLE TO BE REPLICATED DUE TO THE POST-MANUFACTURING DAMAGE. LOCKING THE SLIDER BAR WITH THE RETURNED NUT COMPONENT WAS ABLE TO BE REPLICATED AT CUSTOMER QUALITY AND THE COMPONENTS WERE ABLE TO BE ASSEMBLED. HOWEVER DUE TO BENT CONDITION OF TIPS ON BOTH MAIN SHAFT AND SLIDER BAR, THE OVERALL COMPLAINT CONDITION WAS CONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION), AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN AND APPLICATION WHEN USED AS RECOMMENDED. DIMENSIONAL ANALYSIS WAS DETERMINED TO BE INAPPLICABLE FOR THE RETURNED DEVICE AS ACCURATE DIMENSIONS COULD NOT BE OBTAINED DUE TO BENT AND TWISTED CONDITIONS. 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. ALSO, BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT ANY ISSUES WITH MATERIAL OR MATERIAL PROPERTIES CONTRIBUTED TO THE COMPLAINT CONDITION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT UNINTENDED FORCES SUCH AS EXCESSIVE TWISTING ENCOUNTERED BY THE DEVICE DURING USAGE COULD HAVE CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SLIDING PIECE ON THE INTER-LOCK SCREWDRIVER IS BENT PREVENTING THE PIECE TO LOCK. THERE WAS ANOTHER SCREWDRIVER READILY AVAILABLE. THERE IS NO PATIENT INVOLVEMENT. DURING MANUFACTURER¿S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE DISTAL TIP OF THE SLIDER BAR WAS SLIGHTLY BENT. ADDITIONALLY, THE DISTAL TIP OF THE MAIN DRIVER SHAFT WAS OBSERVED TO BE SIGNIFICANTLY TWISTED IN THE DIRECTION OF RESISTANCE PROVIDED DURING SCREW INSERTION. THIS CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360585 INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9171677 10886982068941

    Patients

    Seq Age Sex Outcome Treatment
    1