BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 12128411 · Received July 7, 2021

    Report

    Report Number
    2939274-2021-03450
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 14, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTO
    UDI-DI
    10886982273963
    PMA / PMN Number
    K111437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    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: G4. H7. H9: 3008812560-10/26/2020-001-C. H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: SUPPLIER ¿ MARK TWO ENGINEERING / INSPECTED AND PACKAGED BY: MONUMENT RELEASE TO WAREHOUSE DATE: 26-MAY-2020. EXPIRATION DATE: 30-APR-2030. PART NUMBER: 03.404.018S, 11MM REAMER HEAD FOR RIA 2-STERILE. LOT NUMBER: 56P5560 (STERILE). LOT QUANTITY: 50. PRODUCTION ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PACKAGING LABEL LOG (PLL) WAS REVIEWED AND DETERMINED TO BE CONFORMING. PACKAGING BOM WAS REVIEWED AND DETERMINED TO BE CONFORMING WITH NO DEVIATIONS TO NORMAL PACKAGING IDENTIFIED. SCN WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 03.404.M018. LOT NUMBER: 6982003. LOT QUANTITY: 315. INSPECTION INSTRUCTION MET ALL INSPECTION ACCEPTANCE CRITERIA. INSPECTION SHEET, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE DATED 28-APR-2020 WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATION FOR HEAT TREAT DATED 27-MAR-2020 WAS REVIEWED AND DETERMINED TO BE CONFORMING. RAW MATERIAL CERTIFICATION DATED 25-NOV-2019 WAS REVIEWED AND DETERMINED TO BE CONFORMING. RAW MATERIAL CERTIFICATE OF TESTS DATED 11-JUN-2019 WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H6: 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 · 1

    PRODUCT COMPLAINT # (B)(4). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE REAMER HEAD FOR REAMER IRRIGATOR ASPIRATOR (RIA) 2 BROKE APART WHILE USE IN THE OPERATING ROOM. REAMER HEAD BROKE OFF 4 PIECES DURING THE SURGICAL CASE. ONE WAS FOUND IN THE PATIENT'S FEMUR CANAL ON X-RAY AFTER REMOVAL OF THE FEMORAL NAIL AND USE OF THE REAMER. TWO PIECES IN THE REAMER SHAFT FOLLOWING SUCTIONING, AND ONE PIECE WAS FOUND ON THE STERILE TABLE UPON COMPLETION OF THE CASE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN FEMORAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN REAMER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 11.0MM REAMER HEAD FOR RIA 2 STERILE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024474 11.0MM REAMER HEAD FOR RIA 2 STERILE REAMER HTO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.404.018S 56P5560 10886982273963

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - NAILS: FEMORAL| UNK - REAMERS