BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE

    MDR report key: 9978324 · Received April 20, 2020

    Report

    Report Number
    8030965-2020-02944
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Report Date
    February 14, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819069510
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER IS A SYNTHES EMPLOYEE. PART #: 313.970, SYNTHES LOT NUMBER: H212158, SUPPLIER LOT NUMBER: H212158, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: APRIL 26, 2017, SUPPLIER: (B)(4). REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RECEIVED HOLDING SLEEVE IS IN A USED CONDITION. THE HOUSING SPRING IS MISSING AS REPORTED. OTHERWISE NO OTHER DAMAGES/ISSUES COULD BE OBSERVED. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DIMENSIONAL INSPECTION: THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. SUMMARY: DUE THE MISSING SPRING, THE COMPLAINT CONDITION IS RATED AS CONFIRMED. UNFORTUNATELY, WE ONLY HAVE LIMITED INFORMATION IN THE COMPLAINT DESCRIPTION AND CANNOT DETERMINE HOW THE SPRING GOT LOST. BY THE EVIDENCE, THAT THE DEVICE PASSED OUR 100% FINAL INSPECTION BEFORE THE DEVICE LEFT THE MANUFACTURING SITE, WE CONFIRM THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCE'S. THE SPRING GOT MOST LIKELY LOST DURING OR AFTER STERILIZATION PROCESS WHERE THE DEVICE GOT DISASSEMBLED DUE TO CLEANING REASONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT DURING LOAN KIT INSPECTION IT WAS DISCOVERED THAT THE INTERNAL SPRING TO THE HOLDING SLEEVE HAD DETACHED FROM THE HOLDERS. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE, IT WAS IDENTIFIED THAT THE HOUSING SPRING IS MISSING. THIS PRODUCT CONDITION WAS REASSESSED AND DETERMINED AS REPORTABLE ON (B)(6) 2020. THIS REPORT INVOLVES ONE (1) HOLDING SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441562 HOLDING SLEEVE SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH H212158 07611819069510

    Patients

    Seq Age Sex Outcome Treatment
    1