BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICPROBE Ø2.8 L230

    MDR report key: 6095041 · Received November 11, 2016

    Report

    Report Number
    2520274-2016-15345
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY IT WAS DETECTED THAT THE WOODEN HANDLED INSTRUMENT OF A SET APPEARED TO HAVE TINY WOODEN SPLINTERS SHEARING AWAY WHILE IT WAS BEING USED FOR HAMMERING. THE HOSPITAL CHECKED THE OTHER TWO (2) SETS AND WEAR AND TEAR WERE NOTED IN ALL THREE (3) KITS. AFTER TROUBLESHOOTING THEY WERE ABLE TO REPLACE THE SCREW WITHOUT THE SURGERY BEING PROLONGED. NO INFORMATION ABOUT PATIENT CONDITION RECEIVED. CONCOMITANT REPORTED PART: 1X SCREW (PART AND LOT NUMBER UNKNOWN). THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747210 PEDICPROBE Ø2.8 L230 PROBE HXB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 1X SCREW (PART AND LOT NUMBER UNKNOWN)