BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA

    MDR report key: 19606736 · Received June 25, 2024

    Report

    Report Number
    1221934-2024-02199
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 21, 2024
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    LXH
    UDI-DI
    10886705007042
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI: (B)(4). THE LOT NUMBER WAS UNKNOWN. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE WAS UNKNOWN. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY: THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTO INVESTIGATION REVEALED THAT GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA SHOWS THE 2 PIECES WITH NO STRUCTURAL ANOMALIES, HOWEVER, THE LATERAL GUIDE PIN THAT HOLDS THE 2 PIECES TOGETHER IS MISSING. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE CAN BE ATTRIBUTED TO THE LOSS OF THE PIN DURING THE RETURN SHIPMENT OF THE LOAN KIT, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION SUMMARY : THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE DEVICE COMES IN USED CONDITION. THE 2 PIECES HAVE NO STRUCTURAL ANOMALIES, HOWEVER, THE LATERAL GUIDE PIN THAT HOLDS THE 2 PIECES TOGETHER IS MISSING. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE CAN BE ATTRIBUTED TO THE LOSS OF THE PIN DURING THE RETURN SHIPMENT OF THE LOAN KIT, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION, IT WAS OBSERVED THAT THE GRAFT PREP SYS SLIDERUNIT DEVICE WAS MISSING A SCREW TO KEEP IT TOGETHER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102569 GRAFT PREP SYS SLIDERUNIT (2 REQ) *EA ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY MITEK LLC US 10886705007042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown