BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6773782 · Received August 8, 2017

    Report

    Report Number
    2520274-2017-12056
    Event Type
    Injury
    Date Received
    August 8, 2017
    Report Date
    July 12, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN NUMBER OF CANCELLOUS SCREWS WHICH BROKE POSTOPERATIVELY. PART AND LOT NUMBERS ARE UNKNOWN. WITHOUT THE SPECIFIC PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE (510K): UNKNOWN, AS SPECIFIC PART NUMBER FOR SCREW IS NOT PROVIDED. 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. 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

    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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS INITIALLY IMPLANTED WITH LOCKING COMPRESSION PLATE (LCP) AND UNKNOWN NUMBER OF SCREWS ON (B)(6) 2015. POSTOPERATIVELY ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE MULTIPLE CANCELLOUS SCREW HEADS ARE BROKEN. REVISION SURGERY WAS PERFORMED ON (B)(6) 2016. NO INFORMATION ABOUT PATIENT STATUS. CONCOMITANT DEVICE REPORTED: TI LCP(TM) DISTAL FEMUR PLATE 7 HOLES/196 MM-RIGHT (PART # 422.252, LOT # 8192220, QUANTITY 1). THIS REPORT IS FOR UNKNOWN NUMBER OF CANCELLOUS SCREWS WHICH BROKE POSTOPERATIVELY. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554127 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention PLATE (PART # 422.252, LOT # 8192220, QUANTITY 1)