BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE(TM) SCREWDRIVER T15

    MDR report key: 12707786 · Received October 27, 2021

    Report

    Report Number
    2939274-2021-06336
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Report Date
    October 2, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188533
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. VISUAL INSPECTION: THE SD DRIVE(TM) SCREWDRIVER T15 (P/N: 314.115, LOT NUMBER: 4920230) WAS RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE HANDLE OF THE DRIVER IS CRACKED THROUGH THE DOWEL PIN. ADDITIONALLY, RUST WAS OBSERVED AROUND THE HANDLE AREA. NO OTHER ISSUE WAS DETECTED FOR THE RETURNED DEVICE. DEVICE FAILURE/DEFECT WAS IDENTIFIED. THE COMPLAINT WAS CONFIRMED. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. INVESTIGATION CONCLUSION: THIS COMPLAINT WAS CONFIRMED AS THE HANDLE OF THE DEVICE WAS CRACKED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. NO NEW, UNIQUE, OR DIFFERENT PATIENT HARMS WERE IDENTIFIED BECAUSE 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 HISTORY LOT PART #: 314.115 , SYNTHES LOT #: 4920230, SUPPLIER LOT #: N/A , RELEASE TO WAREHOUSE DATE: 19 JAN 2005, MANUFACTURED BY: BRANDYWINE, NO NCR'S GENERATED DURING PRODUCTION. DEVICE HISTORY REVIEW REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE HANDLE OF THE INSTRUMENT WAS FOUND TO BE CRACKED IN TWO PLACES. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STARDRIVE(TM) SCREWDRIVER T15. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600430 STARDRIVE(TM) SCREWDRIVER T15 SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.115 4920230 10886982188533

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown