BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDULLARY REAMER Ø7 L385

    MDR report key: 3160561 · Received June 10, 2013

    Report

    Report Number
    1719045-2013-01561
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    June 13, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 HAS BEEN REQUESTED. THE PROVIDED MEDULLARY REAMER WAS INSPECTED BY CHECKING ITS MATERIAL AND PRODUCTION DOCUMENTATION, AND THE REPORTS SHOW COMPLIANCE WITH ALL REGULATIONS AND SPECIFICATIONS. A PRODUCTION ERROR CAN BE EXCLUDED BASED ON THESE RESULTS. THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE VISUAL AND PROVIDED DAMAGE PATTERN. HOWEVER, IT IS POSSIBLE THAT A BRIEF MECHANICAL OVERLOAD EXCEEDED THE LOAD LIMIT ON DRILL HEADS WELD SEEM, WHICH EVENTUALLY LEAD THE MATERIAL TO RUPTURE OR CAUSED A FATIGUE FRACTURE. NO PRODUCT DEFECT WAS ESTABLISHED THE COMPLAINT WAS DETERMINED TO BE INDETERMINATE.

    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    AT FIRST USE DURING SURGERY THE DRILL HEAD DETACHED ITSELF FROM WAVE. NO EXCESSIVE FORCE, NO MISHANDLING OR MISUSE WAS REPORTED. THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261138 MEDULLARY REAMER Ø7 L385 HTO SYNTHES MONUMENT 6657671

    Patients

    Seq Age Sex Outcome Treatment
    1