BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    135 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE

    MDR report key: 8871113 · Received August 7, 2019

    Report

    Report Number
    8030965-2019-66954
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    June 9, 2019
    Report Date
    July 9, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819821217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    IT WAS REPORTED THAT THE PLATE DIDN'T SLIDE ON THE SCREW. THERE WAS ONLY ONE (1) SCREW INVOLVED IN THIS INCIDENT. SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PART: 02.224.224S, LOT: L200509. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: DECEMBER 09, 2016; EXPIRY DATE: DECEMBER 01, 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING FRACTURE REDUCTION FOR A LEFT PERTROCHANTERIC FRACTURE ON (B)(6) 2019, THE DYNAMIC HIP SYSTEM (DHS) PLATE WOULD NOT SLIDE IN THE SCREW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT IS FOR A 135 DEGREE LOCKING COMPRESSION PLATE (LCP) DHS PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664104 135 DEG LCP DHS PLATE-STANDARD BARREL 4 HOLES/92MM-STERILE APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L200509 07611819821217

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR