BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER

    MDR report key: 4171046 · Received October 14, 2014

    Report

    Report Number
    3003875359-2014-10318
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE DEVICE IS IN GOOD CONDITION. NO DAMAGE OR DEVIATION VISIBLE. THE CUTTING EDGES ARE WORN OUT. 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

    ADDITIONAL NARRATIVE: 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A OPERATION WITH A DYNAMIC HIP SYSTEM (DHS) THE PIN BROKE DURING REAMING WITH A DRILL BIT. THERE WAS NO PATIENT INJURY REPORTED. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS IS REPORT NUMBER 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650763 8.0MM DRILL BIT FOR DHS/DCS TRIPLE REAMER BIT,DRILL HTW SYNTHES HAGENDORF 8820322

    Patients

    Seq Age Sex Outcome Treatment
    1