BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMP + DEPUY CMW 1 50G

    MDR report key: 12066665 · Received June 25, 2021

    Report

    Report Number
    1818910-2021-13569
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    April 2, 2021
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # ==> (B)(4) INVESTIGATION SUMMARY ==> THE COMPLAINT STATES: ¿BONE CEMENT WAS DAMAGED AND PHYSICIAN COULDN`T USE THEM AT ALL. NO CONSEQUENCES FOR THE PATIENT REPORTED.¿ THE DEVICE WAS RETURNED FOR INVESTIGATION (SEE ATTACHMENT ¿(B)(4) PHOTOS.PDF¿). THE RETURNED DEVICE WAS NOT IN ITS ORIGINAL COMPLETE PACKAGING. THE TRANSIT CAP FOR THE SYRINGE HAS FRACTURED AROUND 30% OF ITS DIAMETER. THIS CONFIRMS THE COMPLAINT DESCRIPTION. THE FRACTURE APPEARS SPIRAL AND INDICATES POSSIBLE OVERTIGHTENING DURING PACKING OR ADDITIONAL STRESS DURING TRANSIT. TWO NEW TORQUE MACHINES WERE INSTALLED AND VALIDATED IN 2017 UNDER CAPA-002454. EM-014315 OF CAPA-002454 CONFIRMS THAT COMPLAINTS RELATING TO TRANSIT CAPS IN THE 6 MONTHS AFTER THE NEW MACHINES CAME ONLINE REDUCED BY 80%. DVA-104409-FDE REV 10 WAS REVIEWED, AND THIS POSSIBLE FAILURE MODE IS INCLUDED IN LINES 98 TO 103 (SEE ATTACHMENT ¿(B)(4) EXTRACT FROM DVA-104409-FDE,PDF¿). IN EACH CASE THE RISK IS CONSIDERED AS LOW AS POSSIBLE AND CANNOT BE FURTHER MITIGATED. THERE HAVE BEEN 0 OTHER COMPLAINTS FOR TRANSIT CAP ISSUES IN THE PAST 12 MONTHS. IN CONCLUSION THIS APPEARS TO BE A RANDOM COMPONENT FAILURE, AND IT IS NOT POSSIBLE TO DETERMINE ROOT CAUSE. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY THE NUMBER OF COMPLAINTS RECEIVED FOR THIS FAILURE MODE WILL CONTINUE TO BE MONITORED AND PRODUCT UPDATES/ RECOMMENDATIONS WILL BE IMPLEMENTED AT THE POST MARKET SURVEILLANCE REVIEW DEPENDENT UPON OCCURRENCE RATINGS. 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 REQUIRED. DEVICE HISTORY LOT ==> DEVICE HISTORY REVIEWED: 0 NON-CONFORMANCES ON THIS LOT NUMBER. FINAL MICRO AND STERILITY TESTS PASSED. ALL QC RELEASE SPECIFICATIONS MET. (B)(4) RELEASED. LOT EXPIRY DATE: 30 NOVEMBER 2021 H10 ADDITIONAL NARRATIVE: ADDED: D4 (EXPIRATION DATE)

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS RECEIVED FOR EXAMINATION. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE AMPULE BROKEN, INCOMPLETE PACKAGING WAS RECEIVED. AS THE PACKAGING LAYER CONTAINING THE LIQUID CEMENT AMPULE WAS NOT RETURNED IT IS NOT POSSIBLE TO DETERMINE OR ESTABLISH A ROOT CAUSE. 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 ==> A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND TWO NONCONFORMANCE RECORDED ON THIS BATCH THAT WAS RELATED TO PROCESS CONTROLS AND DID NOT IMPACT ON THE OVERALL PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT STATES: ¿BONE CEMENT WAS DAMAGED AND PHYSICIAN COULDN`T USE THEM AT ALL. NO CONSEQUENCES FOR THE PATIENT REPORTED.¿ THE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED DEVICE WAS NOT IN ITS ORIGINAL COMPLETE PACKAGING. THE TRANSIT CAP FOR THE SYRINGE HAS FRACTURED AROUND 30% OF ITS DIAMETER. THIS CONFIRMS THE COMPLAINT DESCRIPTION. 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

    IT WAS REPORTED THAT THE CEMENT WAS DAMAGED AND PHYSICIAN COULDN`T USE THEM AT ALL. NO CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965479 VMP + DEPUY CMW 1 50G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 9264682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown