BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE REVERSE TRAY

    MDR report key: 6846102 · Received September 6, 2017

    Report

    Report Number
    0001825034-2017-06965
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 7, 2017
    Report Date
    January 5, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: XL-115366 ACROM XL 44-41 STD HMRL BRNG LOT # 937390. 180555 COMP LK SCR 3.5HEX 4.75X40 ST LOT # 005060. 115320 COMP RVRS SHLDR GLNSP STD 41MM LOT # 073340. 118001 VERSA-DIAL/COMP TI STD TAPER LOT # 357470. 180554 COMP LK SCR 3.5HEX 4.75X35 ST LOT # 095420. 115370 COMP RVS TRAY CO 44MM LOT 271670. 115397 COMP RVS CNTRL 6.5X35MM ST/RST LOT 064180. 113636 COMP PRIMARY STEM 16MM MINI LOT 412630. 405880 COMP REV FIXED DRL GD LOT # 930530. 405889 COMP RVS 2.7MM DIA DRL LOT # 054640. 405883 COMP RVS 3.2MM DRL LOT # 872730. 115330 COMP RVRS SHDR GLEN BSPLT +HA LOT # 803120. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED ROOT CAUSE WAS DETERMINED TO BE RELATED TO OPERATIONAL CONTEXT CONTRIBUTING TO THE EVENT. IT WAS STATED THAT THE SCRUB TECH DID NOT FULLY UNDERSTAND HOW TO USE THE LOCKING RING SEPARATOR TOOL SINCE IT WAS HIS FIRST TIME. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS NOT BEEN RETURNED; HOWEVER, AN INVESTIGATION HAS BEEN INITIATED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVERSE TOTAL SHOULDER PROCEDURE, THE LOCKING RING WAS FOUND BROKEN. ANOTHER WAS AVAILABLE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625871 COMPREHENSIVE REVERSE TRAY PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 279470

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR