BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPARE REAMER TUBE FOR HOLLOW REAMER

    MDR report key: 3070645 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-10916
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    September 26, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH 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. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED WITH THE HEAD BROKEN OFF AND ALL TEETH BROKEN OFF. THE SURFACE OF THE BROKEN INSTRUMENT IS HOMOGENEOUS AND IS A RESULT OF ORIGINAL CONFORM MATERIAL CONDITION. THE DHR REVIEW SHOWS THAT THE MANUFACTURING PROCESS HAS BEEN ACCORDING TO THE SPECIFICATIONS AS WELL. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE BREAKAGE IS POSSIBLY INDICATIVE OF A MECHANICAL OVERLOADING DURING USAGE. NO PRODUCT OR MATERIAL RELATED CONDITION WAS FOUND. THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT.

    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) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED FEMUR SCREW REMOVAL, THE END OF THE REAMER BROKE OFF THE HOLLOW REAMER. ALL BROKEN PIECES WERE RETRIEVED FROM THE WOUND. THE SURGEON COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171400 SPARE REAMER TUBE FOR HOLLOW REAMER HTO SYNTHES GMBH 2017091

    Patients

    Seq Age Sex Outcome Treatment
    1