BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 6750633 · Received July 28, 2017

    Report

    Report Number
    1719045-2017-10713
    Event Type
    Malfunction
    Date Received
    July 28, 2017
    Date of Event
    June 30, 2017
    Report Date
    June 30, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTJ
    UDI-DI
    07611819707238
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. A VISUAL INSPECTION, DEVICE HISTORY RECORD REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE DEVICE WAS RETURNED AND IT WAS REPORTED THAT "THE INSTRUMENT BROKE OFF." THIS CONDITION IS CONFIRMED; THE INSTRUMENT WAS RETURNED WITH THE NEEDLE COMPONENT BROKEN FROM THE DEPTH GAUGE SLIDER. THE NEEDLE COMPONENT WAS OBSERVED TO BE SLIGHTLY BENT. THE PROTECTION SLEEVE COMPONENT WAS NOT RETURNED AND IS MISSING FROM THE INSTRUMENT. THE BALANCE OF THE RETURNED DEVICE IS IN WORN CONDITION, THE HANDLE OF THE DEPTH GAUGE IS DISCOLORED AND THERE ARE SCRATCHES ALONG THE LENGTH OF THE INSTRUMENT. RELEVANT DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE 319.006 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS IS AN INSTRUMENT ROUTINELY USED TO MEASURE THE DEPTH OF THE HOLES FOR THE 2.0MM/2.4MM SCREWS TO ENSURE THE CORRECT SCREW LENGTH IS USED DURING THE PROCEDURE. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THIS COMPLAINT CONDITION IS LIKELY DUE TO REPEATED USAGE OF THE INSTRUMENT, LEADING TO CUMULATIVE WEAR, EXPOSURE TO VARIOUS INTRA-OPERATIVE FORCES AND EXPOSURE TO SEVERAL STERILIZATION (THERMAL) CYCLES THROUGHOUT THE SERVICE LIFE OF THE DEVICE. ADDITIONALLY, THIS CONDITION CAN BE POSSIBLY DUE TO BENDING FORCE(S) APPLIED TO THE NEEDLE COMPONENT BEYOND THE YIELD LIMIT OF THE MATERIAL. 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

    PATIENT IDENTIFIER NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. HOSPITAL CONTACT TELEPHONE NOT AVAILABLE FOR REPORTING. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW FOR PART #319.006 LOT #9972964. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 07-SEP-2016. SUPPLIER: (B)(4). 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017, THE DEPTH GAUGE BROKE WHILE SURGEON WAS ATTEMPTING TO MEASURE FOR SCREW DEPTH. SURGEON NOTED THE DEPTH GAUGE MAY HAVE BEEN INSERTED IN A DIFFERENT DIRECTION FROM THE HOLE TO BE MEASURED. ALL FRAGMENTS WERE RETRIEVED AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO REPORTED HARM TO PATIENT. THIS REPORT IS FOR ONE (1) DEPTH GAUGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533013 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES MONUMENT 9972964 07611819707238

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR