BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    MDR report key: 6396770 · Received March 10, 2017

    Report

    Report Number
    1719045-2017-10216
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 10, 2017
    Report Date
    February 14, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. IT IS UNKNOWN WHEN THE SUBJECT DEVICE WAS BROKEN. IT WAS DISCOVERED TO BE BROKEN ON (B)(6) 2017. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS REQUESTED FOR THE SUBJECT DEVICE LOT. 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

    DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED FOR PART# 319.006, LOT# 9972964. SUPPLIER: (B)(6), RELEASE TO WAREHOUSE DATE: (B)(6) 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT DEVELOPMENT INVESTIGATION HAS BEEN COMPLETED. A VISUAL INSPECTION, DRAWING REVIEW AND DHR REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT IS CONFIRMED. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. THE RETURNED DEPTH GAUGE WAS FOUND TO HAVE THE NEEDLE BROKEN OFF OF THE SLIDER AT THE THREADS. THE THREADED PORTION OF THE NEEDLE IS RETAINED INSIDE THE SLIDER. NO ISSUES WERE NOTED WITH THE REMAINDER OF THE DEVICE. NO ADDITIONAL MALFUNCTIONS WERE OBSERVED DURING INVESTIGATION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THE NEEDLE WAS LIKELY EXPOSED TO ROUGH HANDLING OR OFF AXIS FORCE DURING USE. 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

    SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A ROUTINE PREOPERATIVE INSTRUMENT INSPECTION ON (B)(6) 2017, THE DEPTH GAUGE WAS FOUND TO BE BROKEN. THE REPORTED DEVICE WAS SUPPOSED TO BE USED IN SURGERY FOR METACARPAL FRACTURE ON (B)(6) 2017. ANOTHER DEPTH GAUGE WAS AVAILABLE FOR USE DURING THE SURGERY. THERE WAS NO PATIENT OR PROCEDURAL INVOLVEMENT REPORTEDLY ASSOCIATED WITH THE COMPLAINT CONDITION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176875 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS GAUGE, DEPTH HTJ SYNTHES MONUMENT 9972964 07611819707238

    Patients

    Seq Age Sex Outcome Treatment
    1