BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4828449 · Received June 9, 2015

    Report

    Report Number
    2520274-2015-14350
    Event Type
    Injury
    Date Received
    June 9, 2015
    Report Date
    May 20, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. AGE NOT PROVIDED BY REPORTER. UNKNOWN WHEN PLATE BROKE. DATE RETURNED TO MANUFACTURER. THIS REPORT IS FOR 11 UNKNOWN SCREWS/UNKNOWN LOT NUMBER. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL POTENTIALLY INVOLVED SCREWS WAS COMPLETED: MANUFACTURING LOCATION: (B)(4). PART 414.876, LOT 2524303: MANUFACTURING DATE: 17SEPTEMBER2009; (LOT 2424309 DOES NOT EXIST); PART 413.330, LOT 7959924: MANUFACTURING DATE: 22JUNE2012; PART 413.338, LOT 8796349: MANUFACTURING DATE: 21JANUARY2014; PART 413.340, LOT 8838598: MANUFACTURING DATE: 15FEBRUARY2014; PART 413.338, LOT 8796349: MANUFACTURING DATE: 21JANUARY2014; PART 413.375, LOT 8990980: MANUFACTURING DATE: 22MAY2014; PART 413.380, LOT 8741770: MANUFACTURING DATE: 02DECEMBER2013; PART 413.380, LOT 9015372: MANUFACTURING DATE: 10JUNE2014; PART 413.375, LOT 8990980: MANUFACTURING DATE: 22MAY2014; PART 413.380, LOT 9015372: MANUFACTURING DATE: 10JUNE2014; PART 413.375, LOT 8990980: MANUFACTURING DATE: 22MAY2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL PATIENT INFORMATION: PATIENT HEIGHT REPORTED AS 165CM. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE KTT. THIS REPORT IS FOR ELEVEN (11) INTACT SCREWS WITH PART/LOT COMBINATIONS AS LISTED BELOW: PART 414.876 / LOT 2524309 - 4.5MM TI CORTEX SCREW SELF-TAPPING 76MM ¿ HWC: SCREW, FIXATION, BONE ¿ OBERDORF - K112583. PART 413.330 / LOT 7959924 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 30MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ MONUMENT - K000682. PART 413.338 / LOT 8796349 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K000682. PART 413.338 / LOT 8796349 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K000682. PART 413.340 / LOT 8838598 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 40MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K023941. PART 413.375 / LOT 8990980 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K023941. PART 413.375 / LOT 8990980 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K023941. PART 413.375 / LOT 8990980 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 75MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K023941. PART 413.380 / LOT 8741770 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 80MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K023941. PART 413.380 / LOT 9015372 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 80MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K023941. PART 413.380 / LOT 9015372 - 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 80MM ¿ KTT: APPLIANCE, FIXATION, NAIL ¿ K023941. PRODUCT INVESTIGATION SUMMARY: ELEVEN (11) INTACT SCREWS WERE RECEIVED. NO PRODUCT FAULT COULD BE DETECTED. (B)(4) USED TO REPORT THE REVISION PROCEDURE THAT OCCURRED DUE TO THE BROKEN PLATE. ALTHOUGH NO ALLEGATIONS HAVE BEEN MADE AGAINST THE SCREWS, THEY CANNOT BE DISASSOCIATED FROM THE EVENT. 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

    REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PROCEDURE WAS DONE: REVISION LISS PLATE, REMOVAL OF BROKEN PLATE AND INSERTION OF VA CONDYLAR PLATE TO FEMUR. PATIENT PRESENTED WITH BROKEN LISS PLATE. REMOVED BROKEN PROSTHESIS AND INSERTED VARIABLE ANGLE CONDYLAR. PATIENT OUTCOME POST SURGICAL PROCEDURE: UNSURE AT THIS TIME. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369893 SCREW, FIXATION, BONE HWC SYNTHES BETTLACH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention