BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVESHAFT FOR SCREWDRIVER 90

    MDR report key: 12713774 · Received October 28, 2021

    Report

    Report Number
    2939274-2021-06371
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Report Date
    October 3, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587013329
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. 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.

    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: H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 · 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: UPDATED DATA: D4. INVESTIGATION SUMMARY VISUAL INSPECTION: THE COMPLAINT DEVICE DRIVESHAFT FOR SCREWDRIVER 90 (PRODUCT CODE: 03.505.006, LOT NUMBER: 8191386) WAS RETURNED TO CQ WEST CHESTER FOR INVESTIGATION. THE DRIVESHAFT WAS RETURNED WITHOUT THE SCREWDRIVER FOR EVALUATION. NO ISSUES WERE IDENTIFIED ON THE DEVICE. FUNCTIONAL TEST: A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE SHAFT WAS NOT RETURNED WITH THE SCREWDRIVER. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S)? NO, THE COMPLAINT CANNOT BE REPLICATED AS A FUNCTIONAL TEST WAS NOT PERFORMED. COMPLAINT CONFIRMED: NO, THE COMPLAINT CONDITION CANNOT BE CONFIRMED DURING PHYSICAL DEVICE INVESTIGATION. CONCLUSION: THE COMPLAINT CONDITION CANNOT BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE 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 HISTORY LOT PART # 03.505.003 . LOT # 8191386 . MANUFACTURING SITE: SELZACH. RELEASE TO WAREHOUSE DATE: 27 AUG 2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. CORRECTED DATA: H3, H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, 90 DEGREE ARM FOR 90 DEGREE SCREWDRIVER DOES NOT CLICK INTO A 90-DEGREE PIECE. THE PIECE IS THE INSERT OF THE 90-DEGREE ARM. THIS WAS DISCOVERED DURING AN INSPECTION WHILE CLEANING IT. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611818 DRIVESHAFT FOR SCREWDRIVER 90 DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.006 8191386 10887587013329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK TURNING HANDLE| UNKNOWN GUIDES/SLEEVES/AIMING| UNKNOWN HANDLES| UNKNOWN INSERTION INSTRUMENTS