BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM DRILL BIT/QC WITH 65MM STOP

    MDR report key: 6689165 · Received July 6, 2017

    Report

    Report Number
    1719045-2017-10631
    Event Type
    Injury
    Date Received
    July 6, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 8, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    UDI-DI
    10705034772745
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 388.394, LOT# U172875. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: AUG 26, 2013. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    (B)(6) REPORTED THE FOLLOWING: IT WAS REPORTED THAT A SYNTHES 2.4MM SYNAPSE DRILL BIT BROKE DURING A C3-C6 POSTERIOR DECOMPRESSION AND INSTRUMENTED FUSION PROCEDURE ON (B)(6) 2017. A PORTION OF THE DRILL BIT THAT BROKE OFF WAS EMBEDDED IN THE PATIENT (C6 PEDICLE). THE SURGEON DID NOT RETRIEVE THE PORTION OF THE DRILL BIT AS IT WOULD CAUSE FURTHER INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 2.4MM DRILL BIT AND NO SURGICAL DELAY WAS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4MM DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471273 2.4MM DRILL BIT/QC WITH 65MM STOP BIT, DRILL HTW SYNTHES MONUMENT 388.394 U172875 10705034772745

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ONE (1) UNKNOWN DRILL