BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 4914930 · Received July 15, 2015

    Report

    Report Number
    2520274-2015-14920
    Event Type
    Injury
    Date Received
    July 15, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 3, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWE
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PER (B)(6), PATIENT INFORMATION IS NOT ABLE TO BE PROVIDED. ADDITIONAL PRODUCT CODES: GFF, GFA, HSZ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 OSTEOSYNTHESIS OF A TIBIA DISTAL FRACTURE A 2.5MM DRILL CRACKED WHILE DRILLING INTO THE CORTICAL BONE OF THE PATIENT. THE BROKEN OFF PIECE REMAINED IN THE PATIENT. THE SURGERY WAS NOT PROLONGED, AS ANOTHER DRILL BIT WAS AVAILABLE FOR USE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460311 2.5MM DRILL BIT/QC/GOLD/110MM INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention