BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® T-HANDLE QC

    MDR report key: 8721870 · Received June 21, 2019

    Report

    Report Number
    2939274-2019-58805
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 23, 2019
    Report Date
    May 24, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXC
    UDI-DI
    10886982193148
    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. THE CUSTOMER REPORTED THE DEVICE WAS NOT CONNECTING PROPERLY AND WAS IMPOSSIBLE TO CLEAN PROPERLY. THE REPAIR TECHNICIAN REPORTED THE DEVICE FAILED ETCH CLARITY AND COSMETICS TESTS. ETCH UNREADABLE IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. VISUAL EXAMINATION UNDER 5X MAGNIFICATION REVEALED A DENT/FLAT ON THE EDGE OF THE INNER CIRCUMFERENCE OF THE DISTAL COUPLING THAT WOULD CONTRIBUTE TO A MATING DEVICE NOT BEING ABLE TO BE LOADED INTO THE RETURNED DEVICE. THE DENT/FLAT IS MAKING THE INSIDE DIAMETER SMALLER. ADDITIONALLY THE ETCH IS FADED. DUE TO POST MANUFACTURING DAMAGE AN ACCURATE DIMENSIONAL INSPECTION COULD NOT BE OBTAINED. A MANUFACTURING RECORD EVALUATION COULD NOT BE DONE AS THE LOT NUMBER COULD NOT BE DETERMINED DUE TO THE FADED ETCH. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A HIP SURGERY. DURING THE SURGERY, THE DYNAMIC HIP AND CONDYLAR SCREW SYSTEM (DHS/DCS) T-HANDLE DID NOT CONNECT AND WAS IMPOSSIBLE TO CLEAN PROPERLY, AND A PINNACLE STRAIGHT CUP IMPACTOR BROKE INTO PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A DHS®/DCS® T-HANDLE QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515385 DHS®/DCS® T-HANDLE QC WRENCH HXC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 338.08 10886982193148

    Patients

    Seq Age Sex Outcome Treatment
    1