BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOCKET WRENCH FOR 12PT NUT 11MM WIDTH ACROSS FLATS

    MDR report key: 3081149 · Received April 26, 2013

    Report

    Report Number
    2530088-2013-10531
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    August 9, 2012
    Report Date
    August 13, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. PLACEHOLDER.

    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 RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. MANUFACTURING EVALUATION REPORTS THAT THE INSTRUMENT WAS RECEIVED IN FOUR PIECES, (THREE BROKEN HANDLE PIECES AND THE SHAFT WITH DOWEL PIN). THE BREAK WAS DOWN THE CENTERLINE, INLINE WITH THE DOWEL PIN, FROM WHERE THE SHAFT ENTERS THE HANDLE, BACK TO THE END OF THE SHAFT ENCAPSULATED IN THE HANDLE (APPROXIMATELY 15 MM PAST THE PIN) AND THEN IT ANGLES SHARPLY OUT TO THE EDGE FOR APPROXIMATELY 20 MM. THERE WERE NO MATERIAL ANOMALIES EVIDENT IN ANY OF THE CRACKED SURFACES. INSTRUMENT WAS MANUFACTURED IN NOVEMBER 2004 AND IS ALMOST 8 YEARS OLD. MATERIAL HARDNESS FOR THE HANDLE COMPONENT WAS NOT VERIFIED DURING THIS EVALUATION BECAUSE NO SPECIFICATION FOR HANDLE MATERIAL HARDNESS EXISTS IN DHR. ALL FEATURES RELATED TO THIS COMPLAINT CONDITION THAT COULD BE VERIFIED DURING THIS EVALUATION MEET SPECIFICATIONS (HANDLE MATERIAL, SHAFT O.D.). HOWEVER, ALL FEATURES RELATED TO THIS COMPLAINT CONDITION COULD NOT BE VERIFIED DUE TO THE DAMAGE (HANDLE BROKE). THEREFORE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    SYNTHES (B)(6) REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SURGEON TIGHTENED THE NUT DOWN ON A USS PEDICLE SCREW BY HAND WITH THE SOCKET WRENCH, AND THE HANDLE BROKE INTO PIECES. ALL THE PIECES WERE RETRIEVED FROM THE PATIENT''S BODY AND THE SURGERY WAS COMPLETED WITH A SECOND SOCKET WRENCH IN THE SET WITHOUT FURTHER INCIDENT. THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181183 SOCKET WRENCH FOR 12PT NUT 11MM WIDTH ACROSS FLATS HXC SYNTHES BRANDYWINE 4888453

    Patients

    Seq Age Sex Outcome Treatment
    1