BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 8878301 · Received August 9, 2019

    Report

    Report Number
    2939274-2019-59624
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 11, 2019
    Report Date
    July 11, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188922
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: H3, H4, H6: THE STARDRIVE SCREWDRIVER SHAFT (PART # 314.467, LOT # 9981815, MFG # 15-MAR-2016) WAS RECEIVED AT US CQ WITH THE DISTAL TIP OF THE SCREWDRIVER TWISTED. THE SCREWDRIVER DOES NOT APPEAR TO BE BENT. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. AFTER A VISUAL INSPECTION, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART NUMBER: 314.467. SYNTHES LOT NUMBER: 9981815. SUPPLIER LOT NUMBER: N/A. RELEASE TO WAREHOUSE DATE: 15MAR2016. EXPIRATION DATE: N/A. MANUFACTURED BY SYNTHES MONUMENT. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL WHEREIN THE PATIENT WAS REVISED WITH A 3.5MM CORTEX SCREW WITH WASHER AND A VARIABLE-ANGLE (VA) ANTEROMEDIAL DISTAL TIBIA PLATE. HOWEVER, UPON FINAL TIGHTENING OF THE SCREWS, THE TIP OF THE TWO (2) STARDRIVE SCREWDRIVER SHAFTS WERE TWISTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: CORTEX SCREW ( PART# 204.850, LOT# UNKNOWN. QUANTITY 1) ; WASHER ( PART# 219.98, LOT# UNKNOWN, QUANTITY 1); PLATE VARIABLE ANGLE ( PART# 02.118.104S, LOT# UNKNOWN, QUANTITY 1) UNKNOWN SCEW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL WHERE THE PATIENT WAS REVISED WITH A 3.5 MM CORTEX SCREW WITH WASHER AND A VARIABLE-ANGLE (VA) ANTEROMEDIAL DISTAL TIBIA PLATE. HOWEVER, UPON FINAL TIGHTENING OF THE SCREWS, THE TIP OF THE TWO (2) STAR DRIVE SCREWDRIVER SHAFTS WERE TWISTED. THE PROCEDURE WAS COMPLETED WITH A BACK -UP SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. CONCOMITANT DEVICE REPORTED: LAG SCREW ( PART# 204.850, LOT# UNKNOWN. QUANTITY 1) ; WASHER ( PART# 219.98, LOT# UNKNOWN, QUANTITY 1); PLATE VARIABLE ANGLE ( PART# 02.118.104S, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4). THIS COMPLAINT IS LINKED TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674646 STARDRIVE SCREWDRIVER SHAFT T8 105MM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.467 9981815 10886982188922

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 2.7/3.5MM VA-LCP DISTAL TIBIA PL/6 H/RT-STER| 3.5MM CORTEX SCREW SELF-TAPPING 50MM| WASHER 7.0MM