BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION/DISTRACTION INSTRUMENT

    MDR report key: 3072965 · Received April 23, 2013

    Report

    Report Number
    8030965-2013-01883
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THIS REPORT IS PART OF THE SERVICE AND REPAIR DOCUMENTATION REMEDIATION. DEVICES THAT WERE RECEIVED BY SERVICE AND REPAIR HAVE EITHER BEEN REPAIRED AND RETURNED TO THE CUSTOMER OR DISCARDED BY SYNTHES, MAKING FURTHER PRODUCT EVALUATION BY MANUFACTURING OR ENGINEERING IMPOSSIBLE. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS LOT HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE WAS FORWARDED TO SERVICE AND REPAIR, ITEM WAS RECEIVED STICKING. ITEM WAS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THERE ARE NO KNOWN NCRS ASSOCIATED WITH THIS PART AND LOT NUMBER. THIS ITEM WAS DISPOSED ON (B)(4) 2013. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT AN IMPLANT/EXPLANT. THE ITEM WAS RECEIVED WITH THE DIAL ONLY MOVING SIX TO EIGHT CLICKS THEN STICKING. A SERVICE HISTORY OF THE PAST THREE YEARS HAS BEEN REVIEWED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, A DIAL ON A COMPRESSION DISTRACTION INSTRUMENT WOULD ONLY MOVE SIX TO EIGHT CLICKS, AND THEN WOULD STICK. THERE WAS NO PATIENT INJURY REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174644 COMPRESSION/DISTRACTION INSTRUMENT JEC SYNTHES GMBH T983737

    Patients

    Seq Age Sex Outcome Treatment
    1