BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT/QC/125MM

    MDR report key: 3898920 · Received June 27, 2014

    Report

    Report Number
    1719045-2014-10281
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZI
    PMA / PMN Number
    PK043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL MANUFACTURE DATE OF 2-20-2014 . SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. NO NON CONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THE SUPPLIER¿S CERTIFICATE OF COMPLIANCE INDICATES THE PARTS WERE MANUFACTURED TO P/N 310.520, REVISION ¿D¿ AND MET THE REQUIRED SPECIFICATIONS. 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

    DATE RECEIVED BY MANUFACTURE ORIGINALLY REPORTED AS (B)(4) 2014 SHOULD BE REPORTED AS (B)(4) 2014. 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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 310.520, LOT U192144 1.8MM DRILL WAS RECEIVED WITH APPROXIMATELY 99MM OF THE WORKING LENGTH BROKEN OFF. THE DISTAL CUTTING TIPS ARE WORN/ BURRED FROM SIGNIFICANT USE; THE SHAFT CONTAINS PROXIMAL ROLL MARKS LIKELY FROM DRILL GUIDE CONTACT DURING USE. THE RETURNED SAMPLE WAS MANUFACTURED IN JANUARY 2014 IS LESS THAN 6 MONTHS OLD, SHOWS CONSIDERABLE WEAR AND BURRS AT THE CUTTING TIPS ALONG WITH SIGNIFICANT ROLL MARKS AT THE PROXIMAL END OF THE BROKEN OFF WORKING LENGTH. THE SPACING OF THE ROLL MARKS IS INDICATIVE OF USE WITH THE RECOMMENDED DRILL GUIDE HOWEVER; ALSO REVEALS SIGNIFICANT AXIAL CONTACT WITH THE DRILL GUIDE. IT IS LIKELY THAT THE USE OF THIS DRILL BIT IN A MUCH WORN CONDITION LED TO THIS COMPLAINT. OVER ANGLING OF THE DRILL BIT INSIDE THE GUIDE LIKELY WAS A CONTRIBUTING FACTOR AS WELL. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. REUSABLE INSTRUMENTS SHOULD BE INSPECTED BETWEEN CASES FOR SUITABILITY OF USE. THE LIKELY METHOD OF USE EMPLOYED WITH THE DRILL BIT LED TO THIS CONFIRMED COMPLAINT AND DOES NOT REFLECT A DEVICE DESIGN DEFICIENCY. 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

    IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2014 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE CALCANEUS, WHILE THE SURGEON WAS USING THE DRILL BIT BEFORE INSERTING THE SCREW, THE DRILL BIT BROKE IN HALF AT THE BASE. NO FRAGMENTS WERE GENERATED AND NO ADDITIONAL TIME WAS ADDED. NO PIECES OF THE DRILL BIT REMAINED IN THE PATIENT AFTER SURGERY. ANOTHER DRILL BIT WAS AVAILABLE IN THE OPERATING ROOM AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377733 1.8MM DRILL BIT/QC/125MM DRILL, BONE, POWERED DZI SYNTHES MONUMENT U192144

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR