BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MBT REV TIB 2 DEG BROACH 37MM

    MDR report key: 11691368 · Received April 19, 2021

    Report

    Report Number
    1818910-2021-08268
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 1, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HTQ
    UDI-DI
    10603295096085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4). INVESTIGATION SUMMARY ==> EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED EVENT. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT ==> PREVIOUS INVESTIGATIONS FOUND THE BLACK ¿O¿ RING USED TO SECURE THE MATING TRIAL STEM HAS STIFFER MECHANICAL PROPERTIES AS COMPARED TO THE STANDARD ORANGE ¿O¿ RING COMPONENTS. THE COMPLAINTS IDENTIFIED FOR THIS FAILURE MODE INVOLVED BROACHES THAT WERE MANUFACTURED IN 2004 AND 2005. THE STIFFER MECHANICAL PROPERTIES OF THE BLACK ¿O¿ RING MAKE ASSEMBLY WITH THE MATING STEM TRIALS DIFFICULT AND SOMETIMES IMPOSSIBLE. THE ROOT CAUSE IS BEING ATTRIBUTED TO SUPPLIER MANUFACTURING UTILIZING THE BLACK ¿O¿ RING. ALL O-RINGS SHOULD MEET THE PRINT SPECIFICATION OF SHORE A HARDNESS 50 (DUROMETER SPECIFICATION). BROACHES SHOULD UTILIZE O-RING SEAL 90000B21-02, WHICH CONTROLS THE AMOUNT OF FORCE NEEDED TO INSERT THE MATING COMPONENT INTO THE BROACH. THE VENDOR (TECOMET) WAS CONTACTED AND SUPPLIED NEW O-RINGS FOR EXAMINATION. THE NEW O-RINGS ALLOWED THE BROACH TO CONNECT TO THE MATING COMPONENT WITH THE APPROPRIATE FORCE. THE NEW O-RINGS WERE ALSO ORANGE IN COLOR AND SOFTER THAN THE BLACK O-RINGS IN THE COMPLAINT PRODUCTS. NO CORRECTIVE ACTION REQUIRED, AS SUPPLIER CORRECTIVE ACTION TAKEN WAS PREVIOUSLY IMPLEMENTED. THE SUPPLIER HAS UPDATED THE METHOD TO OBTAIN O-RINGS FROM THE SPECIFIED MATERIAL AND SOURCE. ALL BROACHES MANUFACTURED BEGINNING IN JANUARY 2007 WILL USE THE CORRECT O-RING.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    DURING THE OPERATING THE DOCTOR FOUND THE FOLLOWING DEFECTS: ON SLEEVE BROACH 37 THE CARD STEMS CANNOT BE PUT ON IT. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. PART NUMBER 860284 NEEDS TO BE REPLACED IT NO LONGER TORQUED. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE. ARTICLE NUMBER 201103080 IS DEFECTIVE. THE PLASTIC IS TORN ON THE INSIDE. IT DID NOT AFFECT THE PATIENT AND THE OR WAS ABLE TO TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581840 MBT REV TIB 2 DEG BROACH 37MM KNEE INSTRUMENT : BROACHES HTQ DEPUY ORTHOPAEDICS INC US 2178-63-111 A0605 10603295096085

    Patients

    Seq Age Sex Outcome Treatment
    1