BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT/QC/125MM

    MDR report key: 4027854 · Received August 21, 2014

    Report

    Report Number
    2520274-2014-13237
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWE
    PMA / PMN Number
    PK962913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODES: HSZ, GFA, & GFF. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED. 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 THE TIP OF A 2.0 MM DRILL TIP BROKE OFF IN THE SHAFT OF THE PATIENT¿S DISTAL TIBIA. THERE WAS NO ADVERSE EVENT AND THE DRILL FRAGMENT WAS LEFT IN THE PATIENT. NO SURGICAL DELAY WAS REPORTED. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504396 2.0MM DRILL BIT/QC/125MM INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR