BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTACK 5MM INSTRUMENT

    MDR report key: 1833613 · Received April 28, 2010

    Report

    Report Number
    2647580-2010-00470
    Event Type
    Malfunction
    Date Received
    April 28, 2010
    Date of Event
    February 24, 2010
    Report Date
    March 11, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    KOG
    PMA / PMN Number
    K963999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). QA AND ENGINEERING EVALUATED ONE OPEN PROTACK 5 MM FIXATION DEVICE. THE INSTRUMENT WAS RECEIVED WITH THE TRIGGER IN THE FULLY ACTUATED POSITION. THE TRIGGER WOULD NOT ACTUATE AS THE DEVICE WAS JAMMED. DISASSEMBLY OF THE PRODUCT REVEALED BINDING OF AN INTERNAL RATCHET PAWL. ENGINEERING WAS ABLE TO DETERMINE THAT THIS CONDITION WAS DUE TO AN IMPROPERLY COATED PAWL. A PROCESS ENHANCEMENT HAS BEEN IMPLEMENTED TO PREVENT RECURRENCE OF THE REPORTED CONDITION. A REVIEW OF HISTORICAL RECORDS SHOWS AN INCREASE IN SIMILAR REPORTS FOR DIFFICULTY FIRING AND JAMMING RECEIVED BETWEEN THE MONTHS OF (B)(6) 2009 TO (B)(6) 2010 FOR EIGHT (8) LOTS AFFECTED BY A COMPONENT RELATED CONDITION. A REMEDIAL FIELD ACTION WAS INITIATED FOR THE PRODUCT AFFECTED BY THIS CONDITION. THE FOLLOWING LOTS WERE INCLUDED IN THE FIELD ACTION: P9M0113, P9M0312, P9M0515, P9M0516, P9M0647, P9M0696, P9M0771 AND P9M0816. ADD'L REVIEW OF HISTORICAL RECORDS SHOWS THAT THERE HAS BEEN ONE (1) REPORT AGAINST LOT P9L0831 FOR DIFFICULTY FIRING AND JAMMING, WITH ONE UNIT RECEIVED FOR INVESTIGATION (B)(4). THERE IS NO STATEMENT IN THE PRODUCT LABELING INDICATING AN EXPECTED FREQUENCY OF OCCURRENCE FOR THIS TYPE OF REPORTED EVENT. THE OBSERVED FREQUENCY FOR SIMILAR EVENTS IS ABOVE HISTORICAL OBSERVATIONS DUE TO THE RECENT COMPONENT DISCREPANCY DETECTED UPON EVAL OF THE 8 RECALL LOTS MFG IN 12/2009. THERE WERE (B)(4) MFG IN 11/2009 WITH ONE REPORT FOR LOT P9L0831, YIELDING AN INCIDENT RATE OF (B)(4). THERE WERE (B)(4) MFG FROM 11/2008 TO 11/2009, YIELDING AN INCIDENT RATE OF (B)(4) PER 1,000 UNITS. THERE WERE (B)(4) REPORTS GENERATED FOR PRODUCTS FROM REORDER CODE (B)(4) FROM THE NON-RECALL POPULATION WITH THE REPORTED CONDITION OF "INSTRUMENT DID NOT FIRE" FROM (B)(6) 2010. THIS INCLUDES ALL "INSTRUMENT DID NOT FIRE" COMPLAINTS REGARDLESS OF THE ROOT CAUSE. THIS REPORTED CONDITION BECAME A REPORTABLE EVENT IN (B)(6) 2010 UPON RECEIPT OF OUR FIRST INJURY RELATED TO THIS CONDITION. THE RECALL IN 2/2010 WAS THE RESULT OF A DISCREET POPULATION OF PROTACK INSTRUMENTS WHICH WERE SUBJECT TO A HIGH FAILURE RATE (APPROX (B)(4)). THE SPECIFIC FAILURE WAS THE DEVICE BECAME INOPERABLE AFTER FIRING THE FIRST TACK AND REQUIRED THE USER TO APPLY ANOTHER DEVICE. WHILE THE FAILURE MODE DOES NOT PRESENT ANY TYPE OF HAZARD; THE HIGH RATE OF FAILURE RESULTED IN A SITUATION WHERE, IN ONE INSTANCE, THE SURGICAL PROCEDURE WAS DELAYED UNTIL A FULLY FUNCTIONAL DEVICE WAS LOCATED. IN THIS PARTICULAR CASE, DUE TO THE HIGH FREQUENCY OF FAILURES, THE USER ATTEMPTED TO FIRE 20 PROTACK DEVICES (ALL FROM THE AFFECTED POPULATION) WITHOUT SUCCESS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE SURGERY, AFTER THE TACKER WAS FIRED THE DEVICE LOCKED UP. THE SECOND PROTACK WAS USED WITH THE SAME RESULT. A THIRD PROTACK WAS USED FROM A DIFFERENT LOT NUMBER AND WORKED FINE. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTACK 5MM INSTRUMENT DISPOSABLE SURGICAL STAPLER KOG USSC PUERTO RICO P9L0831

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR