BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTION HANDLE FOR SUPRAPATELLAR

    MDR report key: 11078240 · Received December 28, 2020

    Report

    Report Number
    2939274-2020-05723
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 30, 2020
    Report Date
    November 30, 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
    GA, US
    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. H3, H4, H6: PART 03.010.440, LOT 180274-101: MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: DECEMBER 28, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION IT WAS NOTICED THAT NOT ALL THE REPORTED DEVICES WERE RETURNED FOR POSSIBLE FUNCTIONAL VERIFICATION. THERE WERE NO DEFECTS NOTICED ON THE DEVICE ITSELF. NOT ALL THE DEVICES WERE RETURNED, BUT THE RETURNED DEVICES WERE PUT TOGETHER AND THERE WAS NO ISSUE IN THE INTERACTION OF THE DEVICES. THE ALIGNMENT CANNOT BE VERIFIED WITH THE PARTIAL DEVICES RETURNED AND NO COMPLETE INFORMATION IS AVAILABLE. THERE WERE NO ISSUES IDENTIFIED WITH THE RETURNED DEVICE THAT COULD HAVE CAUSED THE COMPLAINT CONDITION, SO THE DIMENSIONAL INSPECTION WAS NOT PERFORMED. THE COMPLAINT CONDITION IS NOT CONFIRMED FOR THE RETURNED PART. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICES REPORTED: NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 UNKNOWN PROCEDURE, WHILE DRILLING, THE SURGEON HIT THE NAIL AND DEVICES (INSERTION HANDLE, CANNULATED SCREW, PROTECTION SLEEVE, DRILL SLEEVE, AIMING ARM FOR SUPRATELLAR, TITANIUM CANNULATED TIBIAL NAIL, AND DRILL BIT) DID NOT LINE UP COMPLETELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541483 INSERTION HANDLE FOR SUPRAPATELLAR NAIL, FIXATION, BONE JDS WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.010.440 180274-101 10886982068828

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE| 12.0MM/8.0MM PROTECTION SLEEVE 188MM| 8.0MM/4.2MM DRILL SLEEVE 200MM| AIMING ARM FOR SUPRAPATELLAR| INSERTION HANDLE FOR SUPRAPATELLAR| UNK - NAILS| 11MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE| 12.0MM/8.0MM PROTECTION SLEEVE 188MM| 8.0MM/4.2MM DRILL SLEEVE 200MM| AIMING ARM FOR SUPRAPATELLAR| INSERTION HANDLE FOR SUPRAPATELLAR