BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIT, DRILL

    MDR report key: 5249805 · Received November 25, 2015

    Report

    Report Number
    2520274-2015-17499
    Event Type
    Malfunction
    Date Received
    November 25, 2015
    Report Date
    November 5, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN DRILL BIT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT:ONE 1.8MM COMBINATION DRILL GUIDE, FOR VA-LOCKING AND STANDARD (PART NUMBER 03.111.039, LOT NUMBER 8934812) AND ONE UNKNOWN DRILL BIT WERE RECEIVED WITH THE COMPLAINT THAT DURING ROUTINE INSPECTION IT WAS FOUND THAT THE DRILL GUIDE, PART NUMBER 03.111.039/LOT NUMBER 8934812, WAS MISSING A COMPONENT. AN UNKNOWN DRILL BIT TIP WAS ALSO NOTED AS BROKEN AND IS STUCK IN THE DRILL GUIDE. THE COMPLAINT CONDITION IS CONFIRMED. THE DRILL SLEEVE WAS RECEIVED WITH THE HEAD PIECE COMPONENT, DRILL SLEEVE COMPONENT, AND THE INTERNAL SPRING COMPONENT MISSING FROM THE COMPRESSION SIDE AND THERE IS AN UNKNOWN BROKEN DRILL BIT STUCK IN THE VARIABLE ANGLE (VA) SIDE. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED AS THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION AND THEREFORE, THE SPECIFIC CIRCUMSTANCES AT THE TIME OF THE ISSUES ARE UNKNOWN. IN ADDITION, THE PART NUMBER FOR THE DRILL BIT IS UNKNOWN. HOWEVER, THE ISSUE OF THE BROKEN DRILL BIT THAT IS STUCK IT THE DRILL SLEEVE IS LIKELY THE RESULT OF EXCESSIVE FORCE AS A RESULT OF THE METHOD OF USE AND THE MISSING COMPONENTS ARE LIKELY A RESULT OF DISASSEMBLY FOR CLEANING, AND SUBSEQUENT LOSS OF THE COMPONENTS. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION 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

    IT WAS REPORTED THAT DURING ROUTINE INSPECTION IT WAS FOUND THAT THE DRILL GUIDE WAS MISSING A COMPONENT. THE UNKNOWN DRILL BIT TIP BROKEN INTRAOPERATIVE AND IS STUCK IN THE DRILL GUIDE. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT IS FOR AN UNKNOWN DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779484 BIT, DRILL HTW SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1