BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247MM-RIGHT

    MDR report key: 6300982 · Received February 3, 2017

    Report

    Report Number
    2520274-2017-10378
    Event Type
    Injury
    Date Received
    February 3, 2017
    Report Date
    January 12, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. H10 ADDITIONAL NARRATIVE: H3, H6: INVESTIGATION SUMMARY: REVIEWING ATTACHED PICTURE, THE COMPLAINT DESCRIPTION CAN BE CONFIRMED THAT THE PLATE THROUGH THE THREADED HOLE IS BROKEN. 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 HISTORY LOT: DEVICE HISTORY REVIEW DONE BY (B)(6) ON JUNE 17, 2020. PART NUMBER: 242.808, LOT NUMBER: 6913663, PART MANUFACTURE DATE: APRIL 10, 2012 , MANUFACTURING LOCATION: ELMIRA, PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: 1064259. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 4.5MM LCP PROXIMAL FEMUR PLATE WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCES OR REWORK NOTED. THE LOT QUANTITY OF 12 PIECES MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE RAW MATERIAL REVEALED NO COMPLAINT RELATED ANOMALIES. THE 2 PARTS SCRAPPED AT OP 0020 ¿ LIMS INSPECTION ARE UNRELATED TO THE COMPLAINT CONDITION. NCR 1064259 WAS GENERATED TO CORRECT THE SULFUR CONTENT ON THE SUPPLIER CERTIFICATE OF TESTS. THIS NON-CONFORMANCE IS UNRELATED TO THE COMPLAINT CONDITION. THE DEVICE HISTORY RECORD SHOWS THIS LOT MET ALL REQUIREMENTS AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW: THE LOT QUANTITY OF 12 PIECES MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE 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 DEVICE PRODUCT CODE: HWC. CORRECTED DATA: 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 USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN PLATE FEMORAL/UNKNOWN LOT NUMBER. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). 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

    REPORTER FACILITY CONTACT NUMBER (B)(6). 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A LOCKING COMPRESSION PLATE (LCP) BROKE ON THE RIGHT FEMUR. IT WAS IMPLANTED ON (B)(6) 2014 AND THE REVISION TOOK PLACE ON (B)(6) 2014. COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO A PROXIMAL FEMORAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83509 4.5MM LCP PROXIMAL FEMUR PLATE 8 HOLES/247MM-RIGHT PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 6913663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention