BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREPHINE ATTACHMENT 7.0MM DIAMETER

    MDR report key: 3021522 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10562
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    April 18, 2012
    Report Date
    April 18, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION AND ONE OF THE TEETH WAS BROKEN OFF THE DEVICE. THE REST OF THE DEVICE WAS NOT DAMAGED. A REVIEW OF THE PRODUCT DRAWING INDICATED THAT THE PART WAS MADE FROM APPROPRIATE MATERIAL FOR SURGICAL CUTTING INSTRUMENTATION. A REVIEW OF THE DESIGN & CLINICAL RISK MANAGEMENT DETERMINED THAT THE RATE OF OCCURRENCE IS NOT INDICATIVE OF ANY TRENDS, ESPECIALLY GIVEN THESE ARE MULTI-USE INSTRUMENTS. THIS COMPLAINT IS DEEMED INVALID FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2012.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BONE BIOPSY OF THE CALCANEOUS, ONE OF THE TEETH ON THE TREPHINE ATTACHMENT BROKE OFF WHILE THE SURGEON WAS ROTATING THE DEVICE INTO THE BONE. THE BROKEN FRAGMENT WAS RETRIEVED AND DISCARADED. THE SURGEON USED A CURETTE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123132 TREPHINE ATTACHMENT 7.0MM DIAMETER HSB SYNTHES GMBH 2616628

    Patients

    Seq Age Sex Outcome Treatment
    1