BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM

    MDR report key: 3033539 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-01345
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. TIP OF THE DRILL BIT IS BROKEN OFF. THE CUTTING EDGES HAVE CLEARLY VISIBLE NICKS AND DENTS AND ARE COMPLETELY BLUNT. THE RELEVANT DIMENSIONS CAN NOT BE VERIFIED ANYMORE WITHOUT THE BROKEN FRAGMENT AND BECAUSE THE CUTTING EDGES ARE DAMAGED. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATED MATERIAL CONFORMITY. BASED ON THE APPEARANCE OF THE CUTTING EDGES WE CAN ONLY ASSUME THAT AN EXCESSIVE METALLIC CONTACT OR THE USE OF A BLUNT INSTRUMENT CAUSED A MECHANICAL OVERLOAD AND FINALLY THE BREAKAGE OF THE DRILL BIT.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DURING OLECRANON SURGERY ON (B)(6) 2013, WHILE USING THE POWER ATTACHMENT OF THE DRILL, THE DRILL BIT SNAPPED OFF AND IS RETAINED IN THE PATIENTS BONE. THERE WAS NO ATTEMPT MADE TO REMOVE IT. SURGERY WAS NOT PROLONGED. THE REMAINDER OF THE SURGERY REPORTEDLY WENT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136645 2.0MM DRILL BIT WITH DEPTH MARK/QC/140MM HTW SYNTHES GMBH 8210857

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR