BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 55MM

    MDR report key: 8950961 · Received August 30, 2019

    Report

    Report Number
    2939274-2019-60231
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Report Date
    August 2, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188854
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS A SYNTHES EMPLOYEE. INVESTIGATION SUMMARY: IT WAS REPORTED THAT DURING AN INVENTORY OF THE METRO SETS ON (B)(6) 2019, IT WAS FOUND OUT THAT THE TIP OF A T8 STAR DRIVE SCREWDRIVER SHAFT WAS ROUNDING OFF AND WAS NO LONGER FUNCTIONING CORRECTLY. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE STAR DRIVE SCREWDRIVER SHAFT T8 55 MM (P/N 314.453, LOT # 3240482) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL TIP OF DEVICE WAS WORN AND STRIPPED. THE ETCHING WAS ALSO OBSERVED TO FADE. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DIMENSIONAL INSPECTION OF THE TIP WAS NOT CONDUCTED DUE TO THE POST MANUFACTURING DEFORMATION. THE DEVICE RECEIVED WAS STRIPPED AND WORN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED FOR THE STAR DRIVE SCREWDRIVER SHAFT T8 55 MM (P/N 314.453, LOT # 3240482) AS THE DEVICE WAS STRIPPED AND WORN. THE DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BUT THE POTENTIAL CAUSE COULD BE DUE TO THE USAGE OF THE DEVICE OVER THE 9+ YEARS. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART: 314.453. LOT: 3240482. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: SEPTEMBER 08, 2009. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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 DURING AN INVENTORY OF THE METRO SETS ON (B)(6) 2019, IT WAS FOUND OUT THAT THE TIP OF A T8 STAR DRIVE SCREWDRIVER SHAFT WAS ROUNDING OFF AND WAS NO LONGER FUNCTIONING CORRECTLY. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744967 STARDRIVE SCREWDRIVER SHAFT T8 55MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.453 3240482 10886982188854

    Patients

    Seq Age Sex Outcome Treatment
    1