BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC

    MDR report key: 10991660 · Received December 11, 2020

    Report

    Report Number
    2939274-2020-05551
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Report Date
    November 16, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    07611819926721
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: D4: LOT D9 H3, H4, H6: PART # 03.614.018. SYNTHES LOT # 6070266. SUPPLIER LOT # 6070266. RELEASE TO WAREHOUSE DATE: APRIL 22, 2019. MANUFACTURED BY SYNTHES MONUMENT. NO NCR'S WERE GENERATED DURING PRODUCTION. 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. VISUAL INSPECTION: THESCRDRIVER SHAFT CROSS PINNED T15 (PART #: 03.614.018, LOT #: 6070266) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE DISTAL END (STARDRIVE TIP) WAS FRACTURED. THE CRACKED WAS THIN AND OCCURRED AT THE INSERTION POINT OF THE DWELL PIN (PART # 03.614.018.2). NO OTHER DAMAGE OR ISSUE WAS OBSERVED ON THE RETURNED DEVICE DEVICE FAILURE/DEFECT IDENTIFIED? YES DIMENSIONAL INSPECTION: SPECIFIED DIMENSIONS: SHAFT MAJOR OD = 4.5 +0/- 0.05MM. FLAT OD = 3.65 +0/- 0.1MM. MEASURED DIMENSIONS: SHAFT MAJOR OD = CONFORMING. FLAT OD = CONFORMING. DEVICE USED ¿ HAND MICROMETER OM141P. SPECIFIED DIMENSIONS: PIN OD = 1.5 +0.012/+0.005MM PIN LENGTH = 9.0 +0/- 0.2MM MEASURED DIMENSIONS: PIN OD = CONFORMING. PIN LENGTH = CONFORMING. DEVICE USED ¿ HAND MICROMETER OM141P. SPECIFIED DIMENSION: STARDRIVE MAJOR OD (FEATURE A) = 3.274 +/-0.005MM MEASURED DIMENSION: STARDRIVE MAJOR OD (FEATURE A) = CONFORM. DEVICE USED ¿ HAND MICROMETER OM141P. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CONFIRMED AS THE RETURNED DEVICE WAS FOUND TO HAVE A SMALL CRACK AT THE DISTAL TIP AT THE DWELL PIN INSERTION LOCATION. HOWEVER THE RETURNED DEVICE WAS NOT BROKEN INTO TWO PIECES AS ALL PARTS ARE STILL ATTACHED. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION BUT IT IS LIKELY THE FRACTURE WAS DUE TO A DEVICE OR COMPONENT FAILURE. 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 PREVENTIVE 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

    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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON REGULAR CLEANING, AND INSPECTION OF INSTRUMENTS, IT WAS IDENTIFIED THAT THE SYNAPSE STAR DRIVE SCREWDRIVER SHAFT HAD MICRO FRACTURES AT THE TIP OF THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CROSS PINNED STRDRV SCREWDRIVER SHAFT SELF-RETAINING T15/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455748 CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6070266 07611819926721

    Patients

    Seq Age Sex Outcome Treatment
    1