BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT/EXTRACTOR F/INFANT-HIP-PL+MINI-IN

    MDR report key: 3173938 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03441
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    June 15, 2011
    Report Date
    June 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. OUR INVESTIGATION FOUND THAT ONE OF THE PLATE HOLDING JAWS ON THE INSTRUMENTS TIP WAS BROKEN OFF. WE SUPPOSE THAT A MECHANICAL OVERLOADING SITUATION LED TO THE BREAKAGE. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. WE HAVE TO ASSUME THAT THE OVERLOADING SITUATION WAS DUE TO A FORCIBLE TIGHTENING WHICH MAY HAVE CAUSED THE BREAKAGE. SUCH OVERLOADING SITUATIONS CAN OCCUR IF THE PLATE WAS NOT INSERTED WELL DOWN INTO THE PRONGS. IT WAS NOTED THAT THE GENTAMICIN USED MAY HAVE NO INFLUENCE ON THE BREAKAGE. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED. CONCLUSION: THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WE ASSUME THAT THE OVERLOADING SITUATION WAS DUE TO A FORCIBLE TIGHTENING WHICH MAY HAVE CAUSED THE BREAKAGE. THUS, THE DEVICE FAILURE IS RELATED TO THE CONDITIONS OF USE AND OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PART OF THE INSTRUMENT BROKE OFF. DURING THE SURGICAL OPERATION, THE SURGEON SET A PLATE ON TO THIS INSERTER. HE TIGHTENED THE NUT WITH A WRENCH AND THEN SOAKED THE DEVICE IN GENTAMICIN WATER - 200ML AT 35 DEGREES C FOR 10 MINUTES. THE SURGICAL STAFF HEARD A BANG AND FOUND A PART OF THE INSTRUMENT WAS BROKEN OFF. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273711 INSERT/EXTRACTOR F/INFANT-HIP-PL+MINI-IN HWB SYNTHES GMBH 2481829

    Patients

    Seq Age Sex Outcome Treatment
    1