BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM / TI CANN FRN / PF 400MM / RIGHT - STERILE

    MDR report key: 8617126 · Received May 16, 2019

    Report

    Report Number
    2939274-2019-58120
    Event Type
    Injury
    Date Received
    May 16, 2019
    Report Date
    April 17, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982272454
    PMA / PMN Number
    K172157
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 04.033.140S, LOT: L771253, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 01. MAR. 2018, EXPIRY DATE: 30. JAN. 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE RAW MATERIAL WAS CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE 11 MM/TI CANNULATED FEMORAL RECON NAIL/ PIRIFORMIS FOSSA 400MM/RIGHT ¿ STERILE (PART # 04.033.140S, LOT # L771253, MFG # 01-MAR-2018) WAS RECEIVED AT US CQ WITH THE DISTAL PORTION OF THE NAIL BROKEN AT THE 3RD HOLE FROM THE BOTTOM. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. DIMENSIONAL INSPECTION: DIMENSIONAL ANALYSIS WAS COMPLETED, THE DIMENSION CLOSE TO THE FRACTURE SITE MEASURED AND IS WITHIN SPECIFICATION BASED ON RELEVANT DRAWING. DOCUMENT/SPECIFICATION REVIEW: THE RELEVANT DRAWING(S) WAS REVIEWED; CONCLUSION: THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION NAILING PROCEDURE TO REMOVE THE BROKEN NAIL WITH A NEW NAIL IMPLANTED. THE PATIENT WAS FIRST TREATED ON (B)(6) 2018, THE PATIENT FOLLOWED UP WITH A BROKEN NAIL. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY 1), RECON SCREW (PART/LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A NAIL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408088 11MM / TI CANN FRN / PF 400MM / RIGHT - STERILE ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.033.140S L771253 10886982272454

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - SCREWS: LOCKING| UNKNOWN - SCREW RECON| UNK - SCREWS: LOCKING| UNKNOWN - SCREW RECON