BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM

    MDR report key: 7309525 · Received March 2, 2018

    Report

    Report Number
    3005985723-2018-00102
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    February 2, 2018
    Report Date
    May 7, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THIS IS A REUSABLE INSTRUMENT AND THEREFORE SHOULD NOT HAVE AN EXPIRATION DATE (D4). AN EVENT REGARDING PRODUCT MIX INVOLVING A MAKO BASEPLATE TRIAL WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: THE PRODUCTS WERE RETURNED WITH THE PACKAGING. TWO BASEPLATE TRIALS WERE RETURNED, CATALOG 170604 LOT 26080916. THE TRIALS WERE IN NEW CONDITION. BOTH BASEPLATE TRIALS HAD CATALOG #170604 ON DEVICE WITH PACKAGE LABELS FOR INSERT TRIALS, CATALOG 170706-1 LOT NUMBER 12371116. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. -PRODUCT HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN 7 OTHER EVENTS FOR THE LOT INDICATED. CONCLUSIONS: THE INVESTIGATION CONFIRMED THE REPORTED EVENT OF A PRODUCT MIX BETWEEN THE TRIAL BASEPLATE AND TRIAL INSERT. NC WAS ISSUED ON 15-MAY-2017 FOR THE PRODUCT MIX. THE NC DETERMINED THE ROOT CAUSE OF THIS EVENT WAS A LACK OF STANDARD WORK WHERE PERSONNEL DID NOT PERFORM PROPER LINE CLEARANCE DUE TO A LACK OF TRAINING.

    Description of Event or Problem · 0

    RECEIVED PART NUMBER 170706-1 FROM AN ORDER, BUT IT IS THE WRONG ITEM IN THE PACKAGING.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    RECEIVED PART NUMBER 170706-1 FROM AN ORDER, BUT IT IS THE WRONG ITEM IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153314 TIBIAL INSERT ONLAY TRIAL-SIZE 6-8MM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. 12371116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other