BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAIL CLAMP ASSEMBLY

    MDR report key: 8632859 · Received May 22, 2019

    Report

    Report Number
    3005985723-2019-00369
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 13, 2019
    Report Date
    August 13, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: -CUSTOMER REPORTED THAT WHILE ATTACHING THE STRYKER LEG POSITIONER CLAMP TO THE BED RAIL, 2 PIECES OF THE CLAMP BROKE OFF AND WE WERE UNABLE TO REPAIR OR USE THE INSTRUMENT. DEVICE EVALUATION AND RESULTS: -DEVICE EVALUATION WAS NOT PERFORMED AND THE RAIL CLAMP ASSEMBLY EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: -REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 50 DEVICES WERE MANUFACTURED AND INSPECTED ON 03-31-2017, THEY WERE ACCEPTED WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: -BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING THE RAIL CLAMP ASSEMBLY. THERE HAS BEEN 10 OTHER EVENTS FOR THE REFERENCED LOT NUMBER. PRS # 1579488, 1716880, 1802085, 1845671, 1856633, 1868102, 1909890, 1952517, 1963210 AND 2080314 - WERE FOUND TO BE FROM THE SAME LOT AS THE PART IN THIS COMPLAINT. THE PARTS FROM THESE PRS DISPLAYED THE SAME FAILURE. CONCLUSIONS: -FROM THE IMAGE PROVIDED: THE RAIL CLAMP ASSEMBLY SHOWED A BROKEN 210042 (RAIL CLAMP LOWER) PART, WHICH IS A COMPONENT OF THE 210040 RAIL CLAMP ASSEMBLY. OVER TORQUEING OF THE CLAMP SCREW CAUSE THE PART TO BREAK. CORRECTIVE ACTION/PREVENTIVE ACTION: -AS THE EVENT DID NOT INVOLVE A MANUFACTURING RELATED PRODUCT PROBLEM INDICATING A NON-CONFORMITY, ADVERSE TREND, OR UNANTICIPATED HAZARD, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    WHILE ATTACHING THE STRYKER LEG POSITIONER CLAMP TO THE BED RAIL, 2 PIECES OF THE CLAMP BROKE OFF AND WE WERE UNABLE TO REPAIR OR USE THE INSTRUMENT. WE WERE ABLE TO RETRIEVE THE BROKEN PIECES. THIS WAS THE SECOND CLAMP THIS HAPPENED TO IN THE SAME CASE. REFERENCE (B)(4) FOR 1ST EVENT. CASE TYPE: TKA SURGICAL DELAY: =15 MINUTES 1. WAS THE PATIENT UNDER ANESTHESIA? "YES PATIENT WAS UNDER ANESTHESIA BUT THE PROCEDURE HAD NOT STARTED YET". 2. DID THE LEG FALL OFF THE TABLE? "YES HE WAS ATTEMPTING TO ATTACH THE CLAMP TO THE BED RAIL BUT THERE WAS NO IMPACT TO THE PATIENTS LEG OR ANYTHING ON THE PATIENT AT ALL".

    Additional Manufacturer Narrative · 1

    AS PART OF THE NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    WHILE ATTACHING THE STRYKER LEG POSITIONER CLAMP TO THE BED RAIL, 2 PIECES OF THE CLAMP BROKE OFF AND WE WERE UNABLE TO REPAIR OR USE THE INSTRUMENT. WE WERE ABLE TO RETRIEVE THE BROKEN PIECES. THIS WAS THE SECOND CLAMP THIS HAPPENED TO IN THE SAME CASE. REFERENCE (B)(4) FOR 1ST EVENT. CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES WAS THE PATIENT UNDER ANESTHESIA? "YES PATIENT WAS UNDER ANESTHESIA BUT THE PROCEDURE HAD NOT STARTED YET". DID THE LEG FALL OFF THE TABLE? "YES HE WAS ATTEMPTING TO ATTACH THE CLAMP TO THE BED RAIL BUT THERE WAS NO IMPACT TO THE PATIENTS LEG OR ANYTHING ON THE PATIENT AT ALL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424138 RAIL CLAMP ASSEMBLY STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 19550816 00848486031831

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization