BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIC-INSTR F/STERNAL ZIPFIX

    MDR report key: 3193545 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04160
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    September 27, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE PERFORMED FUNCTIONAL TEST WITH THE RETURNED INSTRUMENT HAS SHOWN THAT IT IS IMPOSSIBLE TO APPLY FULL TENSION TO THE INSERTED IMPLANT, WHEN THE SMOOTH SIDE OF THE ZIPFIX IS PLACED ONTO THE SLIDER TOOTH SURFACE. AFTER THIS FUNCTIONAL TEST WE PERFORMED THE FOLLOWING ADDITIONAL EVALUATIONS. THE GRIPPING SURFACE OF THE SLIDER WAS VISUALLY INSPECTED AND NO IRREGULARITY OR INCORRECT PRODUCTION FINISH WAS OBSERVED. THE SLIDER- SPRINGS WERE 1.1 NEWTON, 1.73 NEWTON AND 1.55 NEWTON RESPECTIVELY. THE 1.1 NEWTON WAS MEASURED ON THE RETURNED INSTRUMENT. THE ROOT CAUSE OF THE IMPLANT SLIPPING THROUGH THE SLIDER IS RELATED TO THE LOWER SPRING FORCE APPLIED TO THE SLIDER OF THE INSTRUMENT. HOWEVER, BASED ON THE PROVIDED DETAIL THE EXACT CAUSE OF THIS OCCURRENCE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TENSION MECHANISM DOES NOT WORK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292294 APPLIC-INSTR F/STERNAL ZIPFIX JDQ SYNTHES GMBH 7505075

    Patients

    Seq Age Sex Outcome Treatment
    1