BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 11214578 · Received January 22, 2021

    Report

    Report Number
    2939274-2021-00404
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    December 29, 2020
    Report Date
    December 29, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDS
    UDI-DI
    10886982068828
    PMA / PMN Number
    K111667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D4: LOT. D9 H3, H4, H6: PART# 03.010.440. LOT# 160139-101. MANUFACTURING LOCATION: SELZACH. SUPPLIER: LEITNER AG. MANUFACTURING DATE: JULY 22, 2016. NO NCRS 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. VISUAL INSPECTION: THE INSERTION HANDLE FOR SUPRAPATELLAR (P/N: 03.010.440, LOT NUMBER: 160139-101) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO DAMAGE OBSERVED. THE BROKEN OFF TIP OF THE RETURNED MATING DEVICE WAS ABLE TO BE REMOVED FROM THE COMPLAINT DEVICE WITHOUT DIFFICULTY. DEVICE FAILURE/DEFECT IDENTIFIED? NO. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS NO DEFECTS WERE IDENTIFIED WITH THE COMPLAINT DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR 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

    IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN SUPRAPATELLAR PROCEDURE FOR TIBIAL NAIL THE DRIVING CAP BROKE DURING INSERTION OF THE TIBIAL NAIL. THERE WERE NO FRAGMENTS GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF 15 MINUTES. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: DRIVING CAP (PART NUMBER 03.010.475, LOT UNKNOWN, QUANTITY 1) THIS REPORT INVOLVES ONE (1) INSERTION HANDLE FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109971 INSERTION HANDLE FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 160139-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1 DRIVING CAP| DRIVING CAP