BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3192653 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03533
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 9, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. (B)(6). 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. OUR INVESTIGATIONS HAVE SHOWN THAT ONE SEALING TIP/EDGE OF THE INSTRUMENT IS INDEED BROKEN OFF. ALSO THE SCREW IS BADLY DAMAGED. THEREFORE WE DO SUPPOSE THAT A MECHANICAL OVERLOADING BY TIGHTENING THE SCREW WITH THE WRENCH MAY HAVE CAUSED THE BREAKAGE. THE BROKEN SURFACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. THE MANUFACTURING REOCRDS AND DRAWINGS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEATING CHISEL WAS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294174 INSERT/EXTRACTOR F/INFANT-HIP-PL+MINI-IN HWB SYNTHES USA 2664323

    Patients

    Seq Age Sex Outcome Treatment
    1