BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECH

    MDR report key: 13938011 · Received March 29, 2022

    Report

    Report Number
    1038671-2022-10001
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    February 20, 2017
    Report Date
    March 14, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF AN FDA INSPECTION CONDUCTED IN JAN 2020, EXACTECH, FEI (B)(4), HAS COMMITTED TO REMEDIATING 3 YEARS OF COMPLAINTS (2017-2020). THIS MDR IS BEING SUBMITTED AS PART OF THAT REMEDIATION. THE DEVICE IN QUESTION WAS RETURNED TO EXACTECH FOR ANALYSIS. DESIGN RELATED ISSUES: THIS DESIGN HAS BEEN IN THE FIELD SINCE 1995. AT THE TIME OF THIS ANALYSIS, 31 MAY 2018, EXACTECH HAD RECEIVED 13 SIMILAR COMPLAINTS INVOLVING 13 FEMORAL FINISHING GUIDES SINCE 2008. THE TOTAL CALCULATE OCCURRENCE RATE OF <0.5% IS CONSIDERED "VERY LOW" ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE; THEREFORE, THIS ISSUE DOES NOT APPEAR TO BE DESIGN RELATED. MANUFACTURING: EXACTECH HAD NOT RECEIVED ANY OTHER COMPLAINT INVOLVING PARTS FROM THIS MANUFACTURING LOT WHICH HAS BEEN IN THE FIELD SINCE 2006. THIS ISSUE DOES NOT APPEAR TO BE MANUFACTURING RELATED. RISK MANAGEMENT: A REVIEW OF THE RISK MANAGEMENT REPORT (RMR) WAS CONDUCTED AND FOUND THE OCCURRENCE RATE IS BELOW THE PREDICTED THRESHOLD. THE RMR FOR TIS FEMORAL FINISHING GUIDE, 750-1992-001-RMR REV - AND THE RISK IS CAPTURED IN LINE 13. EXACTECH IFU 700-096-004 STATES: THE SURGEON SHALL BECOME THOROUGHLY FAMILIAR WITH THE TECHNIQUE OF IMPLANTATION OF THE PROSTHESES BY: APPROPRIATE READING OF THE LITERATURE, AND TRAINING IN THE OPERATIVE SKILLS AND TECHNIQUES REQUIRED FOR TOTAL KNEE ARTHROPLASTY SURGERY, AND REVIEWING INFORMATION REGARDING USE OF INSTRUMENTATION. IT IS A CLINICAL STANDARD OF PRACTICE IN THE OPERATING ROOM THAT ALL INSTRUMENTS SHOULD BE VISUALLY AND FUNCTIONALLY INSPECTED BEFORE USE, THESE GUIDELINES ARE FROM STANDARD ASSOCIATION OF PERI-OPERATIVE REGISTERED NURSES (AORN) GUIDELINES. SURGEONS ARE TO BE FAMILIAR AND KNOWLEDGEABLE WITH ALL EXACTECH INSTRUMENTATION, DEVICES AND PROFICIENT WITH SURGICAL TECHNIQUES. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. BASED ON A REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO REASONABLY SUGGEST THE REPORTED INSTRUMENT MALFUNCTION IS RELATED TO ANY MANUFACTURING ISSUES OR DESIGN ISSUES, NOR DID IT LEAD TO ANY REPORTED PATIENT IMPACT. AN INVESTIGATION WAS CONDUCTED THAT THE MOST LIKELY ROOT CAUSE OF THE DISASSEMBLY REPORTED IN THIS EVENT WAS LIKELY DUE TO A HIGH ENERGY EVENT, SUCH AS DROPPING THE INSTRUMENT ONTO A HARD SURFACE WHICH CAUSED THE PEGS TO DETACH FROM THE REST OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ORTHOPEDIC KNEE SURGERY THE SURGEON EXPERIENCED THE SIZE 4 FEMORAL RESECTION BLOCK, THE TWO SHORT METAL PINS THAT FIX THE BLOCK TO THE BONE SHEARED OFF COMPLETELY. THE SALES REPRESENTATIVE WAS NOT PRESENT AT THE SURGERY AND REPORTED NO DEVICE FRAGMENTS FELL INTO THE SURGICAL SITE. THE SURGERY CONTINUED AND WAS COMPLETED WITHOUT ADDITIONAL ISSUES. THERE WAS NO DELAY OF SURGERY AND THERE WAS NO PATIENT INJURY, ADVERSE EVENT, OR CLINICAL CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE REPORTER RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2900078 EXACTECH FEMORAL FINISHING GUIDE SIZE 4 LXH EXACTECH, INC. 15050005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention