BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLD-SL F/SPIRIT PANGEA CLOSED END SHORT

    MDR report key: 3171618 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02712
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    March 14, 2011
    Report Date
    March 24, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    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. 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). DATE RECEIVED BY MANUFACTURER REPORTED INCORRECTLY; DATE IS: (B)(4) 2011. 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. 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION OF THE COMPLAINED HOLDING SLEEVES HAS SHOWN THAT THE CONNECTING SCREW CAME OFF DUE TO EXCESSIVE APPLIED MECHANICAL FORCE IN A SLANTING DIRECTION. PRODUCT FAULT WAS NOT FOUND. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE SCREW CAME OFF FROM HOLDING SLEEVE. THIS IS 2 OF 2 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272503 HOLD-SL F/SPIRIT PANGEA CLOSED END SHORT HXX SYNTHES GMBH 3378949

    Patients

    Seq Age Sex Outcome Treatment
    1