BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE 188MM

    MDR report key: 7940781 · Received October 5, 2018

    Report

    Report Number
    2939274-2018-54209
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 16, 2018
    Report Date
    September 16, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982067371
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. INITIAL REPORTER IS SYNTHES SALES CONSULTANT DHR REVIEW WAS ATTEMPTED. PART: 03.010.063 , SYNTHES LOT NUMBER ¿ 5435329 , LOT NO.: 1621958 , LOT NO.: 003264 . PART/LOT COMBINATION ARE UNKNOWN AT SYNTHES GMBH, NO DHR REVIEW POSSIBLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    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. EVENT DESCRIPTION UPDATE IN MWR-(B)(4) WAS A CORRECTION, NOT ADDITIONAL INFORMATION. DATE REC¿D BY MFR : DATE REPORTED IN MWR-(B)(4) WAS 9/26/2018. CORRECT DATE SHOULD HAVE BEEN 10/29/2018. 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) 2018, A TROCAR ANTEGRADE LOCKING ARM WAS NOT LINING UP WITH THE HOLE OF THE NAIL DURING A RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) PROCEDURE. THE SURGEON WAS ABLE TO INSERT THE SCREW WITH THE WRONG TROCAR SLEEVE. IT APPEARS THAT THERE WAS A WIGGLE OF THE TROCAR PROTECTION SLEEVE IN THE AIMING ARM. THE SURGEON DID A PERFECT CIRCLE THROUGH THE PROXIMAL END OF THE NAIL. THE SURGERY WAS DELAYED APPROXIMATELY 5-10 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICE: TROCAR INSERTION HANDLE CONNECTING SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    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. COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CUSTOMER RETAINING FOR BOTH DEVICES. PART: 03.010.063; LOT NO.: 1621958; LOT NO.: 003264. PART/LOT COMBINATION ARE UNKNOWN AT SYNTHES (B)(4), NO DHR REVIEW POSSIBLE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, A TROCAR ANTEGRADE LOCKING ARM WAS NOT LINING UP WITH THE HOLE OF THE NAIL. IT APPEARS THAT THERE WAS A WIGGLE OF THE TROCAR PROTECTION SLEEVE IN THE AIMING ARM. THE SURGEON DID A PERFECT CIRCLE THROUGH THE PROXIMAL END OF THE NAIL. THE SURGERY WAS DELAYED APPROXIMATELY 5-10 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED AND THE PATIENT OUTCOME IS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN TROCAR INSERTION HANDLE CONNECTING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS COMPLAINT IS FOR (1) 12.0MM/8.0MM PROTECTION SLEEVE 188MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779535 12.0MM/8.0MM PROTECTION SLEEVE 188MM MISC ORTHO SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5435329 10886982067371

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR