BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF TIB RESECT STYLUS ASSY 3MM

    MDR report key: 9334585 · Received November 18, 2019

    Report

    Report Number
    3002806535-2019-00878
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    November 6, 2019
    Report Date
    March 19, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LXH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCTS HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION AND FORWARDED TO THE COMPLAINTS PRODUCT EVALUATION ENGINEER FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE ¿¿SCREWS¿¿ OF THE G-CLAMPS ARE ABLE TO BE REMOVED AS A RESULT OF THE ATTEMPT TO DISASSEMBLE THE INSTRUMENTS. THE DRAWING CALLS FOR THE SCREW TO BE SET AT 3.1MM FROM ITS BASE POINT FOR EFFECTIVE CLAMPING PRESSURE TO BE APPLIED DURING SURGERY. ANY ADJUSTMENT OF THE SCREW CAUSES THE INSTRUMENTS TO LOOSE THE REQUIRED GAP TOLERANCE. THE ITEM WAS MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATION REQUIRED IN DRAWINGS 32-422846 REVISION E AND 32-422863 REVISION E. AN UPDATE TO THE MANUFACTURING SPECIFICATION OCCURRED IN REVISION F WHERE THE SCREW IS PINNED AND WELDED IN POSITION THUS PREVENTING ANY MOVEMENT AFTER FACTORY SETTING. OXFORD PARTIAL KNEE MICROPLASTY INSTRUMENTATION ASSEMBLY / DISASSEMBLY (DOCUMENTATION NO. 2690.1 ¿ OUS ¿ EN REV 1019) INSTRUCTIONS DETAIL THAT THE OXF TIB RESECT STYLUS ASSY IS NOT DESIGNED TO BE DISASSEMBLED. CORRECTIVE ACTIONS: AN UPDATE TO THE MANUFACTURING SPECIFICATION OCCURRED FOR ITEM 32-422863 REVISION: F; PRODUCTION RELEASE ON 24 OCT 2017 AND ITEM 32-422846 REVISION: F; PRODUCTION RELEASE ON 30 NOV 2017 WHERE THE SCREW IS PINNED AND WELDED IN POSITION THUS PREVENTING ANY MOVEMENT AFTER FACTORY SETTING. THE ROOT CAUSE OF THE REPORTED EVENT IS USER ERROR ¿ DISMANTLING DEVICE FOR REPROCESSING PURPOSES. MHR REVIEW: THE MHRS RELATED TO THE INVOLVED PRODUCT HAVE BEEN REVIEWED AND DO NOT SHOW ANY NON-CONFORMITY, REJECTION OR CONCESSION THAT COULD BE RELATED TO THE REPORTED EVENT. THE COMPLAINT SEARCH WAS CARRIED OUT IN ORDER TO ASSESS THE OCCURRENCE OF THE EVENT IN THE INVESTIGATION. THERE WERE 11 ITEMS RETURNED IN THE PERIOD OF (B)(6) 2016 TO (B)(6) 2020. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HOSPITAL THAT DURING STERILIZATION THE INSTRUMENT WAS DISASSEMBLED FOR CLEANING. SUBSEQUENTLY, THE INSTRUMENT WOULD NOT FUNCTION CORRECTLY. THE CONNECTION OF THE OXF TIB RESECT STYLUS ASSY (BOTH VERSIONS) TO THE OXFORD TIBIAL GAP GAUGE WAS NOT WORKING PROPERLY.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF TIB RESECT STYLUS ASSY 4MM CATALOG #: 32-422863 LOT #: ZB120801. ADDITIONAL MDR REPORT WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2019-00877. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT DURING STERILIZATION THE INSTRUMENT WAS DISASSEMBLED FOR CLEANING. SUBSEQUENTLY, THE INSTRUMENT WOULD NOT FUNCTION CORRECTLY. THE CONNECTION OF THE OXF TIB RESECT STYLUS ASSY (BOTH VERSIONS) TO THE OXFORD TIBIAL GAP GAUGE WAS NOT WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1132920 OXF TIB RESECT STYLUS ASSY 3MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH BIOMET UK LTD. N/A ZB121001

    Patients

    Seq Age Sex Outcome Treatment
    1