BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXF MP SLOT POST CUT GD LGE RG

    MDR report key: 9863330 · Received March 21, 2020

    Report

    Report Number
    3002806535-2020-00163
    Event Type
    Malfunction
    Date Received
    March 21, 2020
    Date of Event
    February 24, 2020
    Report Date
    November 19, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: THE EVENT REPORTS: SOMETHING APPEARS TO HAVE BROKEN IN THE MECHANISM, A SMALL CIRCULAR PIECE HAS FALLEN OFF. NO DEBRIS LEFT IN PATIENT. NEED TO REPLACE INSTRUMENT. NO PATIENT HARM, OCCURRED DURING SURGICAL PROCEDURE. A VISUAL CHECK OF THE RETURNED PRODUCT OXFORD MP SLOT POST CUTTING GUIDE LARGE (ITEM 32-422982 LOT. ZB130101) CONFIRMS THAT THE 2.5MM DIAMETER PIN (37-100025-4) IS MISSING FROM THE ASSEMBLY. THE CUTTING GUIDE HAS MANY DINGS, DENTS, BURRS AND SCRATCHES INDICATING THAT IT¿S BEEN USED IN MANY SURGICAL PROCEDURES SINCE ITS MANUFACTURE IN 2013. A DIMENSIONAL INSPECTION IS NOT REQUIRED FOR THIS EVENT AS IT IS FOR A DISASSEMBLY ISSUE. THE MOST LIKELY CAUSE OF THE PIN LOOSENING IS REPEATED STERILISATION CYCLES OVER THE 8 YEARS OF USE IN THE FIELD CAUSING THE PIN TO EXPAND AND CONTRACT CAUSING THE ADHESIVE TO LOSE ADHESION (REF REUSABLE INSTRUMENT LIFESPAN MANUAL 1219.4-GLBL-EN-ISSUE DATE 2021-04-08). THIS PRODUCT LEFT ZIMMER BIOMET CONTROL CONFORMING. A VISUAL INSPECTION OF THIS DEVICE SHOWS THIS EVENT DOES NOT DIFFER FROM PREVIOUS REPORTED EVENTS FOR THE OXFORD MP SLOT POST CUTTING GUIDE LARGE (ITEM 32-422982 LOT. ZB130101) AS A RESULT THERE IS NO CHANGE TO THE SEVERITY OR OCCURRENCE FOR THIS EVENT WITH THE REPORTED EVENT IS STILL CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMF. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G3: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. WE HAVE NOT BEEN PROVIDED WITH ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS FOR THIS ITEM CODE 32-422982. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE. HOWEVER, A PREVIOUS INVESTIGATION UNDER (B)(4) ESTABLISHED A DESIGN CHANGE WAS UNDERTAKEN IN 2018 IN ORDER TO IMPROVE THE METHOD OF FIXATION OF THE PIN AND COLOUR MARKER. THE MANUFACTURING DATE OF THE REPORTED DEVICE IS 2013, WHICH PRE-DATES THE IMPLEMENTATION OF THE DESIGN CHANGE. SINCE A PRODUCT EVALUATION COULD NOT BE CARRIED OUT, IT CANNOT BE CATEGORICALLY CONFIRMED THE ROUTE CAUSE IS SIMILAR TO THAT INVESTIGATED IN (B)(4). RISK MANAGEMENT REPORT (B)(4) REV 04 AND I/O TABLE (B)(4), REV 06 DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. LINE 11.2.3.2 OF RISK FILE (B)(4) REV 06 RELATES TO THE REPORTED EVENT: UNSUITABLE COLOUR MARKING: COLOUR MARKING DETACHES FROM INSTRUMENT. THIS LINE HAS A SEVERITY SCORE OF 4 WHICH IS DEFINED IN THE RMR AS: LIFE THREATENING OR RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DETAILS OF THE REPORTED EVENT STATE THAT THERE WAS LESS THAN A FIVE-MINUTE DELAY TO SURGERY AND NO PATIENT HARM. THE OUTCOME OF THIS COMPLAINT IS CONSIDERED TO BE WITHIN THE SEVERITY OF THE RMR. 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

    T WAS REPORTED THAT SOMETHING APPEARS TO HAVE BROKEN IN THE MECHANISM, A SMALL CIRCULAR PIECE HAS FALLEN OFF. NO DEBRIS LEFT IN PATIENT. NEED TO REPLACE INSTRUMENT. NO DELAY OF THE SURGERY WAS REPORTED. NOT KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOMETHING APPEARS TO HAVE BROKEN IN THE MECHANISM, A SMALL CIRCULAR PIECE HAS FALLEN OFF. NO DEBRIS LEFT IN PATIENT. NEED TO REPLACE INSTRUMENT. NO DELAY OF THE SURGERY WAS REPORTED. NOT KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOMETHING APPEARS TO HAVE BROKEN IN THE MECHANISM, A SMALL CIRCULAR PIECE HAS FALLEN OFF. NO DEBRIS LEFT IN PATIENT. NEED TO REPLACE INSTRUMENT. NO DELAY OF THE SURGERY WAS REPORTED. NOT KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT OR THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326791 OXF MP SLOT POST CUT GD LGE RG ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK, REUSABLE HWA BIOMET UK LTD. N/A ZB130101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown