BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP HOOK PLATE 3 HOLE STERILE

    MDR report key: 7814348 · Received August 24, 2018

    Report

    Report Number
    2939274-2018-53469
    Event Type
    Injury
    Date Received
    August 24, 2018
    Report Date
    August 7, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    UDI-DI
    10886982034731
    PMA / PMN Number
    K082072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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. : DHR REVIEW WAS COMPLETED. PART: 02.113.103S LOT: L831381 MANUFACTURING SITE: MEZZOVICO RELEASE TO WAREHOUSE DATE: 13.APR.2018 EXPIRY DATE: 01.APR.2028 THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 12 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION H3, H6: 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

    DATE OF POSTOPERATIVE SURGICAL WOUND BREAKDOWN AND INFECTION DEVELOPMENT IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF A LOCKING COMPRESSION PLATE (LCP) HOOK PLATE AND TWO (2) 3.5MM CORTEX SCREWS DUE TO SURGICAL WOUND BREAKDOWN AND INFECTION ON (B)(6) 2018. THE PROCEDURE INCLUDED INCISION AND DRAINAGE AND TENSION BAND WITH 18 GAUGE WIRE. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2018. THE PATIENT OUTCOME WAS REPORTED AS OKAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. THIS REPORT IS FOR ONE (1) 3.5MM LCP HOOK PLATE 3 HOLE STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654202 3.5MM LCP HOOK PLATE 3 HOLE STERILE PLATE, FIXATION, BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 02.113.103S L831381 10886982034731

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention