BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE

    MDR report key: 3781462 · Received April 30, 2014

    Report

    Report Number
    9612488-2014-10133
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SYNTHES BETTLACH
    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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 EVALUATION WAS COMPLETED: THE INVESTIGATION HAS SHOWN THAT THE TIP IS BROKEN OFF. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAS LED TO THIS OCCURRENCE. IT IS LIKELY THAT TOO MUCH MECHANICAL FORCE HAD BEEN APPLIED DURING THE SURGERY. PLEASE NOTE; BLUNT DRILL BITS REQUIRE MORE MECHANICAL POWER DURING THE APPLICATION, THEREFORE WE RECOMMEND THAT BLUNT OR DAMAGED INSTRUMENTS NEED TO BE EXCHANGED BEFORE SURGERY. 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: IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR A DISTAL RADIUS BONE FRACTURE, A LOCKING COMPRESSION DISTAL RADIUS PLATE AND FIVE SCREWS WERE USED. AFTER DRILLING, THE SURGEON FOUND THAT THE TIP OF THE DRILL WAS BROKEN. THE SURGEON COULD NOT RETRIEVE THE BROKEN PIECE OF THE DRILL. THE SURGEON DECIDED TO LEAVE THE BROKEN PIECE IN THE PATIENTS BONE. THE SURGICAL PROCEDURE WAS COMPLETED WITH A REPORTED TWENTY MINUTE SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260202 DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE BIT,DRILL HTW SYNTHES BETTLACH 7988018

    Patients

    Seq Age Sex Outcome Treatment
    1