BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3212275 · Received July 9, 2013

    Report

    Report Number
    2520274-2013-04155
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRILL BIT IS MADE FROM HEAT TREATED 440A STAINLESS STEEL, A STANDARD MATERIAL FOR DRILL BITS. CONSIDERING THAT THE COMPLAINT DESCRIPTION INDICATES THE DRILL COLLIDED WITH A GUIDE WIRE, THE COMMON USAGE OF 440A IN DRILL BITS AND THE LOW RATE OF OCCURRENCE, IT IS UNLIKELY THAT THE DESIGN OF THE DRILL WAS A CONTRIBUTING FACTOR IN THIS FAILURE. AS SUCH, THIS COMPLAINT IS DETERMINED TO BE INVALID FROM A DESIGN PERSPECTIVE. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS DATE DEVICE RECEIVED FOR EVALUATION. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DETERMINED DURING DHR REVIEW. (B)(4).

    Description of Event or Problem · 1

    SYNTHES (B)(6) REPORTED: DURING SURGERY FOR A RIGHT DISTAL RADIUS FRACTURE ON (B)(6) 2013: WHILE DRILLING IN THE HEAD OF A 9-HOLE VOLAR PLATE, USING A GUIDE, THE DRILL HIT AN EXISTING K-WIRE AND BROKE. THE SURGEON WAS INFORMED THAT THE DRILL BIT WAS NOT IMPLANT QUALITY. PER THE SURGEON, HE FELT THE RISK OF RETRIEVAL WAS HIGHER THAN THE RISK OF LEAVING IT IN THE PATIENT DUE TO PATIENTS AGE AND HISTORY OF DIABETES. THE SURGEON COMPLETED THE PROCEDURE WITH A DIFFERENT DRILL. THERE WAS NO EXTENSION OF SURGERY OR ADDITIONAL MEDICATION/SEDATION REQUIRED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314314 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM HTW SYNTHES USA 8153037

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR