BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.5MM DRILL BIT/QC/GOLD/110MM

    MDR report key: 6841625 · Received September 5, 2017

    Report

    Report Number
    1719045-2017-10872
    Event Type
    Injury
    Date Received
    September 5, 2017
    Date of Event
    August 11, 2017
    Report Date
    August 11, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWE
    UDI-DI
    10886982186317
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: DHR REVIEW FOR PART #310.25, SYNTHES LOT#U211797. RELEASE TO WAREHOUSE DATE: 19-NOV-2014, 20-NOV-2014. EXPIRATION DATE: N/A. SUPPLIER: ORCHID UNIQUE. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS 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 A DRILL BIT BROKE DURING A LEFT TIBIA NAIL PROCEDURE ON (B)(6) 2017. THE SURGEON WAS DRILLING OUTSIDE OF THE BONE, USING THE DRILL BIT IN AN OFF-LABEL WAY (USING IT AT A BLOCKING FASHION TO MAKE THE NAIL DEFLECT IN A DIFFERENT DIRECTION). THE DRILL BIT BROKE INTO TWO PIECES AND TWO FRAGMENTS FROM THE FLUTED PORTION WERE LEFT IN THE PATIENT¿S DISTAL TIBIA. THERE WAS NO REPORTED SURGICAL DELAY OR ADDITIONAL X-RAYS. THE FINAL CONSTRUCT WAS A TIBIAL NAIL WITH SCREWS. THE PROCEDURE WAS REPORTED COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR ONE(1) DEVICE. CONCOMITANT DEVICES REPORTED: SYNTHES TRAUMA RECON DRILL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622777 2.5MM DRILL BIT/QC/GOLD/110MM INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES MONUMENT U211797 10886982186317

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention SYNTHES TRAUMA RECON DRILL PART/LOT#:UNK, QTY. 1| UNKNOWN NAIL, PART/LOT#:UNK, QTY. UNK