BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLICATION INSTR W/ALIGNMENT GUIDE FOR CRANIAL TUBE CLAMP

    MDR report key: 5706039 · Received June 8, 2016

    Report

    Report Number
    3003862213-2016-10018
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    May 30, 2016
    Report Date
    May 31, 2016
    Manufacturer
    UMKIRCH
    Product Code
    HXQ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED; NO CONCLUSIONS COULD BE DRAWN AS THE DEVICE IS ENTERING THE COMPLAINT SYSTEM. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE APPLICATION INSTRUMENT (PART: 329.323 / LOT: 3076204) WAS RETURNED WITH A REPORT THAT IT WOULD NOT BE SEAT THE CLAMPS AS IT SHOULD. THE COMPLAINT CONDITION WAS LIKELY CAUSED BY DULLNESS AND WEAR FROM OVER SEVEN YEARS OF CONSISTENT USE; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN OR MANUFACTURING RELATED DEFICIENCY. A VISUAL INSPECTION, FUNCTIONAL TEST AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE APPLICATION INSTRUMENT IS ROUTINELY USED IN THE CRANIAL CLAMPS WITH APPLICATION INSTRUMENT SYSTEM. THE CRIMPING AND CUTTING EDGES OF THE RETURNED DEVICE SHOW SOME WEAR AND DULLNESS THAT COULD POSSIBLY PRECLUDE PROPER CLAMP FIXATION. THE DEVICE WAS MANUFACTURED IN JANUARY, 2009 AND IS OVER SEVEN YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN OTHERWISE GOOD CONDITION, ALTHOUGH THE SPRING MECHANISM DOES RUN SOMEWHAT ROUGHLY. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE. UPON REVIEW OF THE DEVICE HISTORY RECORD, NO NON-CONFORMANCES WERE NOTED DURING THE PRODUCTION OF THIS DEVICE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING SITE: (B)(4)- MANUFACTURING DATE: JANUARY 27, 2009. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOPLASTY ON (B)(6) 2016. DURING THE PROCEDURE, THE APPLICATION INSTRUMENT FOR THE CRANIAL TUBE CLAMP DID NOT SEAT THE CLAMPS AS EXPECTED. AN ADDITIONAL INSTRUMENT TRAY WAS AVAILABLE AND OPENED. THE SAME INSTRUMENT FROM THE NEW SET WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A MINOR DELAY OF AN UNSPECIFIED AMOUNT OF TIME WAS NOTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359954 APPLICATION INSTR W/ALIGNMENT GUIDE FOR CRANIAL TUBE CLAMP CRIMPER, PIN HXQ UMKIRCH 3076204

    Patients

    Seq Age Sex Outcome Treatment
    1