BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOCKING SCREW FOR TRANSPALATAL DISTRACTOR

    MDR report key: 5650970 · Received May 12, 2016

    Report

    Report Number
    2520274-2016-12671
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 19, 2016
    Report Date
    April 26, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE WAS NOT IMPLANTED/EXPLANTED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE INVESTIGATION HAS SHOWN THAT ONE QUARTER OF THE SCREW HEAD RECESS IS BROKEN OFF. THE BROKEN OFF PART WAS RETRIEVED BUT WAS NOT RETURNED FOR INVESTIGATION. THE DIMENSION COULD NOT BE VERIFIED DUE TO THE DAMAGE INCURRED. SINCE THE LOT NUMBER OF THE BLOCKING SCREW IS NOT KNOWN THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED AND NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. IT IS LIKELY THAT TOO MUCH STRAIN WAS APPLIED WHICH FINALLY LED TO THE BREAKAGE. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. DEVICE WAS 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 IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY WHILE PLACING THE BLOCKING SCREW INTO THE MODULE, THE SCREW HEAD BROKE OFF SO THEY HAD TO REPLACE THE MODULE. THE SURGEON HAD BEEN USING THE TRANSPALATAL DISTRACTOR (TPD) FOR THREE YEARS. THE SURGERY WAS PROLONGED ABOUT THIRTY (30) MINUTES. NO INFORMATION ABOUT PATIENT'S POST-OPERATIVE CONDITION RECEIVED BUT THERE WAS NO PATIENT HARM. ALL BROKEN OFF FRAGMENTS WERE REMOVED. SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT REPORTED PARTS: ONE TRANSPALATAL DISTRACTOR (PART 04.509.005 LOT 9840186). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306508 BLOCKING SCREW FOR TRANSPALATAL DISTRACTOR BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR