BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 10960324 · Received December 7, 2020

    Report

    Report Number
    8030965-2020-09464
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Report Date
    September 15, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    UDI-DI
    07611819707238
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS A SYNTHES SALES REPRESENTATIVE. PART 319.006, LOT H151615: RELEASE TO WAREHOUSE DATE: DECEMBER 05, 2016. 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. A PRODUCT INVESTIGATION WAS COMPLETED: VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THAT THE SLIDER IS SMOOTHLY-RUNNING. FURTHERMORE, THE HANDLE AS WELL AS THE BLACK COLORED PARTS HAVE DISCOLORATION AREAS. THE NEEDLE IS SLIGHTLY BENT. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. THE DEVICE WAS REASSEMBLED/ ASSEMBLED WITHOUT ANY FUNCTIONAL ISSUE DETECTED. THE SLIDER IS SMOOTHLY-RUNNING. THE REPORTED ISSUE COULD NOT BE REPRODUCED. DIMENSIONAL INSPECTION SHOWED THE RELEVANT DIMENSIONS WERE CONFORMING. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. OUR INVESTIGATION HAS SHOWN THAT THE COMPLAINT CONDITION IS UNCONFIRMED AS THE REPORTED ISSUE COULD NOT BE REPRODUCED. NEVERTHELESS, THE COMPLAINT WILL BE RATED AS CONFIRMED DUE TO THE DAMAGES INCURRED. HOWEVER, THE FINDINGS ABOVE LET US EXCLUDE A MANUFACTURING RELATED ISSUE. FOR THE BENDING ISSUE, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES SUCH AS BEING DROPPED DURING USAGE OR HANDLING. DUE TO THE AGE AND THE STRONG USED CONDITION OF THE DEVICE, WE DO ASSUME THAT THE DEVICE UNDERWENT SEVERAL CLEANING AND STERILIZATION PROCEDURES OVER THE YEARS. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER 15, 2020, THE DEPTH GAUGE WAS DELIVERED TO THE HOSPITAL. WHEN THE HOSPITAL STAFF CHECKED IT, IT WAS FOUND THAT THE DEPTH GAUGE WAS ABOUT TO CAME OFF AT ITS NECK. THE SUBSTITUTE PRODUCT WAS DELIVERED TO THE HOSPITAL. DURING INVESTIGATION BY THE MANUFACTURER, IT WAS NOTED THAT THE NEEDLE IS SLIGHTLY BENT. THIS REPORT IS FOR A DEPTH GAUGE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425435 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES GMBH H151615 07611819707238

    Patients

    Seq Age Sex Outcome Treatment
    1