BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOBUTTON CL

    MDR report key: 23091848 · Received September 18, 2025

    Report

    Report Number
    3006981798-2025-00033
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 18, 2025
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    MBI
    PMA / PMN Number
    K160655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DHR'S FOR ALL LOTS CONFIRMED THERE WERE NO ISSUES WITH THE PRODUCT ITSELF DURING PRODUCTION. ALL FINISHED GOODS TESTING REQUIREMENTS WERE MET PRIOR TO RELEASE. REVIEW OF THE DHR'S FOR ALL FOUR LOTS CONFIRMED A LABELING NONCONFORMANCE. THE PRODUCT INCLUDED ALL LABELS SPECIFIED BY THE CUSTOMER SPECIFICATION DOCUMENT (ISO-BUTTON-SB, ISO-BUTTON-L, AND ISO-BUTTON-P), AND THE POUCH AND PATIENT LABELS INCLUDED ALL REQUIRED ELEMENTS. HOWEVER, THE BOX LABEL (SALES PACKAGING LABEL) WAS MISSING INFORMATION REQUIRED PER DESIGN FILE: DLA0011. REQUIRED ELEMENTS MISSING FROM THE BOX LABEL: - CE MARK. - NAME OF AUTHORIZED EU REPRESENTATIVE. - IFU SYMBOLS ("DO NOT RESTERILIZE", "DO NOT REUSE", MD). - INDICATION OF STERILE BARRIER AND STERILIZATION METHOD. THE CUSTOMER SPECIFICATION DOCUMENT (CS-ISO) REQUIRES A 1 SIDE BOX LABEL, 1 POUCH LABEL, AND 6 PATIENT LABELS FOR THIS PRODUCT. THE LABEL SPECIFICATION DOCUMENT ISO-BUTTON-L01 CONTAINS A SIDE BOX LABEL MISSING THE REQUIRED INFORMATION LISTED ABOVE. THIS WAS ALSO CONFIRMED IN THE INITIAL RELEASE OF THE DOCUMENT PER DCO 177-2021 FINALIZED ON 9/22/2021. INVESTIGATION INTO THE DCO RECORDS FOR THE CUSTOMER SPECIFICATION DOCUMENT (CS-ISO) REVEALED DCO 259-2021 (REV. F TO G) REMOVED THE BACK BOX LABEL REQUIREMENT. PER THE LABEL PROOF, THE BACK BOX LABEL FULFILLED THE MDD REQUIREMENTS FOR THE SALES PACKAGING LABEL. SINCE IT WAS EXCLUDED FROM CS-ISO, AND THE SIDE BOX LABEL DID NOT CONTAIN ALL REQUIRED INFORMATION, THIS RESULTED IN A LABELING NONCONFORMANCE. DCO 984-2025 WAS INITIATED TO ADDRESS THIS NONCONFORMANCE. THE PROPOSED CHANGE ADDS THE BACK BOX LABEL TO THE CUSTOMER SPECIFICATION DOCUMENT. THE HEALTH OF THE PATIENT IS NOT IMPACTED BY THE DEFECT. THE DEFECT IS LIMITED TO THE BOX LABEL ONLY AND THE DEVICE IS NOT IMPACTED. THE CORRECT INFORMATION IS CAPTURED ON THE PATIENT LABEL AND POUCH LABEL, WHICH THE USER WILL EXAMINE AFTER OPENING THE PACK. ALL OTHER INFORMATION ON BOTH LABELS IS CORRECT. THE LABELING DEFECT DOES NOT INTRODUCE A RISK LEADING TO IMPROPER USE. THERE ARE NO NEW OR INCREASED RISKS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE USE OF THE AFFECTED DEVICE. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAS CAUSE OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. RIVERPOINT MEDICAL FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, "THE CUSTOMER INFORMED US THAT THEY HAD RECEIVED TWO UNITS OF THE OBCL-30-TI REFERENCE (BATCH 24042919, EXPIRY DATE 31/03/2029) WITHOUT THE CE MARKING ON THE PRODUCT BOX. AFTER INTERNAL VERIFICATION, IT APPEARS THAT ALL UNITS IN THE OBCL RANGE CURRENTLY IN STOCK AT OUR PREMISES HAVE THE SAME NONCOMPLIANCE. CODE ITEM: LOT: QTY: DESCRIPTION FRENCH, EXPIRY DATE, NON-CONFORMITY REFERENCE OBCL-15-TI 21011237 (B)(4) ENDO BOUTONS RP 15MM STERILE 31/12/2025 (B)(4). OBCL-20-TI 24042917 (B)(4) ENDO BOUTONS RP 20MM STERILE 31/03/2029 (B)(4). OBCL-25-TI 24042918 (B)(4) ENDO BOUTONS RP 25MM STERILE 31/03/2029 (B)(4). OBCL-30-TI 24042919 (B)(4) ENDO BOUTONS RP 30MM STERILE 31/03/2029 (B)(4). IN ADDITION TO THE ABSENCE OF THE CE MARK, OTHER REGULATORY INFORMATION IS ALSO MISSING, INCLUDING: - THE NAME OF THE AUTHORIZED EU REPRESENTATIVE, - THE IFU SYMBOLS, "DO NOT RESTERILIZE," "DO NOT REUSE," "DAMAGED PACKAGING," MD, - THE INDICATION OF THE STERILE BARRIER AND THE STERILIZATION METHOD. WE ARE QUARANTINING ALL OF THE UNITS IN QUESTION WHILE YOU CONDUCT YOUR INVESTIGATION. HOWEVER, I WOULD LIKE TO DRAW YOUR ATTENTION TO THE FOLLOWING POINTS: - BATCH NUMBER 21011237 IS NEARING ITS EXPIRY DATE (12/31/2025), - NO OTHER COMPLIANT BATCHES ARE AVAILABLE FOR THESE FOUR REFERENCES, RESULTING IN AN IMMEDIATE SHORTAGE. IN ORDER TO LIMIT THE OPERATIONAL IMPACT, WE PROPOSE, SUBJECT TO OFFICIAL AUTHORIZATION FROM YOUR REGULATORY AND QUALITY DEPARTMENT. THE PROVISION OF COMPLIANT LABELS, TO CARRY OUT RELABELING AT OUR PREMISES. IN ADDITION, WE WOULD BE GRATEFUL IF YOU COULD PROVIDE US WITH THE FOLLOWING INFORMATION: - THE COMMUNICATION TO BE SENT TO CUSTOMERS WHO HAVE NON-COMPLIANT PRODUCTS IN THEIR POSSESSION, - WHETHER A PRODUCT RECALL SHOULD BE ORGANIZED WITH OUR CUSTOMERS, - OR WHETHER THE USE OF THE PRODUCTS CAN BE AUTHORIZED UNDER COVER OF AN OFFICIAL DOCUMENT SIGNED BY YOUR PCVRR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2868217 ORTHOBUTTON CL WHITE POLYBLEND UHMWPE WITH GREY TITANIUM BUTTON MBI RIVERPOINT MEDICAL LLC OBCL-20-TI 24042917

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown