BEUDAMED
    FDA Adverse Event Injury Summary report: N

    15.0MM REAMER HEAD FOR RIA 2 STERILE

    MDR report key: 10620919 · Received October 2, 2020

    Report

    Report Number
    8030965-2020-07665
    Event Type
    Injury
    Date Received
    October 2, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 21, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRX
    UDI-DI
    07612334142481
    PMA / PMN Number
    K111437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. A2: PATIENT DATE OF BIRTH IS AN UNKNOWN DATE IN 1963. H3, H4, H6: PART:03.404.026S, SYNTHES LOT: 26P3633, SUPPLIER LOT: N/A, RELEASE TO WAREHOUSE DATE: NOVEMBER 15, 2019, EXPIRATION DATE: DECEMBER 01, 2029, SUPPLIER: (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE REAMER HEAD F/RIA 2 Ø15 WAS RECEIVED AT US CUSTOMER QUALITY (CQ). ALL PROXIMAL COUPLING PRONGS WERE BROKEN OFF THE REAMER HEAD. THE RECEIVED X-RAYS SHOWED THAT THE PRONGS REMAINED EMBEDDED IN THE PATIENT. THE RECEIVED CONDITION WAS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT WAS CONFIRMED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO POST-MANUFACTURING DAMAGE DOCUMENT/SPECIFICATION REVIEW: CURRENT & MANUFACTURED REVISIONS WERE REVIEWED. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED REAMER HEAD F/RIA 2 Ø15. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED, IT IS POSSIBLE THE DEVICE EXPERIENCED UNINTENDED FORCES DURING USE. 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 PREVENTATIVE 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.

    Description of Event or Problem · 0

    AT THE INITIAL SURGERY ON (B)(6) THE RIA SYSTEM WAS USED FOR REMOVAL ONLY. THE DONOR SITE WAS NOT TREATED WITH AN IMPLANT DURING THE INITIAL SURGERY. THE FRACTURE AT THE DONOR SITE WAS CREATED ON (B)(6) AND THE SURGERY WAS DONE ON (B)(6) . THE FRACTURE WAS NOT TREATED WITH SYNTHES IMPLANTS. CONCOMITANT DEVICES: RIA 2 MEDULLARY REAMER HEAD (PART: 03.404.024, LOT: 6778009, QUANTITY: 1), RIA 2 MEDULLARY REAMER HEAD (PART: 03.404.029, LOT: 6773014, QUANTITY: 1), RIA 2 MEDULLARY REAMER HEAD (PART: 03.404.028, LOT: 6772013, QUANTITY: 1), DRIVE SHAFT FOR RIA (PART: 03.404.035, LOT: UNKNOWN, QUANTITY 1), SYNREAM DRILL WIRE (PART: 351.706S, LOT: 7L10833, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020, THAT THE PATIENT UNDERWENT FOR A SURGERY ON LEFT PROXIMAL FEMUR. DURING REAMING, THE RIA DRILL HEADS AND THE AREA OF THE SHAFT CENTER OF THE DRIVER SHAFT WAS SOLVED. THE FOUR CLAMPING SPRINGS OF THE DRILL HEAD HAVE ALL BROKEN OFF AND REMAINS IN THE PATIENT. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: DRIVE SHAFT FOR RIA (PART# 03.404.035, LOT# UNKNOWN, QUANTITY 1). SYNREAM DRILL WIRE (PART# 351.706S, LOT# 7L10833, QUANTITY 1). THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR (1) 15.0MM REAMER HEAD FOR RIA 2 STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084743 15.0MM REAMER HEAD FOR RIA 2 STERILE ACCESSORIES, ARTHROSCOPIC HRX OBERDORF SYNTHES PRODUKTIONS GMBH 26P3633 07612334142481

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention DRIVE SHAFT F/RIA 2 L520| DRIVE SHAFT F/RIA 2 L520| REAMER HEAD F/RIA 2 Ø14| REAMER HEAD F/RIA 2 Ø16| REAMER HEAD F/RIA 2 Ø16.5| REAMROD Ø2.5 L950 W/OLIVE| REAMROD Ø2.5 L950 W/OLIVE| DRIVE SHAFT F/RIA 2 L520| REAMROD Ø2.5 L950 W/OLIVE