BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM

    MDR report key: 4296361 · Received December 4, 2014

    Report

    Report Number
    1719045-2014-10655
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 6, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTW
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. (B)(4). ADDITIONAL MANUFACTURING DATES: SEPTEMBER 10, 2013 AND SEPTEMBER 17, 2013. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE 310.509, LOT U172690 1.8MM DRILL BIT WITH DEPTH MARK, QUICK COUPLING WAS RECEIVED INTACT. THE DRILL BIT HAS A BROKEN TIP WHICH LEFT A HOMOGENOUS FRACTURE SURFACE BEGINNING 2MM FROM THE BEGINNING OF THE FLUTING OF THE DISTAL END OF THE BIT. THE BALANCE OF THE DEVICE IS IN GOOD CONDITION. THE DEVICE WAS MANUFACTURED SEPTEMBER 2013 AND IS 1 YEAR OLD. PER THE TECHNIQUE GUIDE, THE 310.509 1.8MM DRILL BIT WITH DEPTH MARK, QUICK COUPLING IS AN INSTRUMENT THAT IS ROUTINELY USED IN NUMEROUS PROCEDURES INCLUDING THE 2.4MM VARIABLE ANGLE LOCKING COMPRESSION PLATE DISTAL RADIUS SYSTEM. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN DURING A DISTAL RADIUS FRACTURE PROCEDURE. THIS CONDITION IS CONFIRMED. IT IS LIKELY THAT THE DEVICE CAME INTO CONTACT WITH SOMETHING HARDER THAN BONE DURING THE PROCEDURE; THE COMPLAINT DESCRIPTION NOTES THAT THE DRILL BIT BROKE AT THE EDGE OF THE PLATE. THE DRAWING FOR THE DEVICE WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. IT IS LIKELY THAT A COLLISION WITH SOMETHING HARDER THAN BONE LED TO THIS CONFIRMED COMPLAINT, HOWEVER THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. 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 THAT A 1.8MM DRILL BIT BROKE AT THE EDGE OF THE PLATE DURING A OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A LEFT DISTAL RADIUS FRACTURE. THE TIP OF THE DRILL BIT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF FIVE TO SIX MINUTES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784536 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM BIT, DRILL HTW SYNTHES MONUMENT U172690

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR