BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM DRILL BIT/MINI QC/65MM

    MDR report key: 3802971 · Received May 9, 2014

    Report

    Report Number
    1719045-2014-10190
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODES: HWE, GFA, GFF AND HSZ. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL RELEASE TO WAREHOUSE DATES: 12/11/13, 2/10/14. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. DHR 310.141 LOT U181772 RELEASED (B)(4) 2013, & (B)(4) 2014. ORCHID UNIQUE MANUFACTURED THE 1.5MM DRILL BIT/MINI QC/65MM, PART NUMBER 310.141, AND LOT NUMBER U181772 FOR SYNTHES PURCHASED ORDERS (B)(4). THE SUPPLIER¿S CERTIFICATES OF COMPLIANCE (DATED (B)(4) 2013, FOR THREE RECEIPTS OF THIS LOT) INDICATE THE PARTS WERE MANUFACTURED TO P/N 310.141, REVISION ¿E¿ AND MET THE REQUIRED SPECIFICATIONS. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES, INCOMING FINAL INSPECTION SHEET NUMBER NS040132, REVISION ¿E¿ (COMPLETED (B)(4) 2013, AND (B)(4) 2014). NONE-CONFORMANCE REPORTS WERE GENERATED FOR THIS LOT. THE THREE RECEIPTS WERE RELEASED (B)(4) 2013, AND (B)(4) 2014. DRAWING 310.141, REV E, WAS RELEASED (B)(4) 2012. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. 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 MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE MATERIAL OF THE DRILL WAS CONFIRMED TO BE CORRECT; THE HARDNESS COULD NOT BE VERIFIED DUE TO THE SMALL PART DIAMETER. THE SHAFT AND COUPLING DIAMETERS OF THE PART WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. BASED ON THE SPECIFICATIONS AT THE TIME OF THE ORIGINAL MANUFACTURING, THE INDETERMINATE ROOT CAUSE, AND THE EVALUATION PERFORMED BY SYNTHES, THIS COMPLAINT IS UNCONFIRMED FROM A MANUFACTURING POSITION. 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 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: DURING PREPARATION, THE SURGEON DISCOVERED THE DRILL BIT WAS BENT, SO HE USED ANOTHER DRILL BIT, HOWEVER, THAT BIT BROKE IN THE PATIENT'S BONE DURING DRILLING. THE SURGEON COULD NOT RETRIEVE THE BROKEN TIP, SO HE DECIDED TO LEAVE THE BROKEN BIT IN THE PATIENT'S BONE AND FINISHED THE OPERATION. SURGERY WAS EXTENDED 30 MINUTES. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281714 1.5MM DRILL BIT/MINI QC/65MM BIT,DRILL HTW SYNTHES MONUMENT U181772

    Patients

    Seq Age Sex Outcome Treatment
    1