BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER STANDARD 0

    MDR report key: 4996075 · Received August 6, 2015

    Report

    Report Number
    1651501-2015-00023
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Report Date
    July 11, 2015
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K130050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RETURNED. THE DEVICE EVALUATION IS IN PROGRESS. THE RESULT OF THE DEVICE EVALUATION WILL BE REPORTED IN A FOLLOW UP MDR SUBMISSION.

    Additional Manufacturer Narrative · 1

    THIS IS THE 2ND OF 3 REPORTS FOR THE SAME EVENT, DIFFERENT PRODUCTS. MFG REPORT NUMBERS: 1651501-2015-00015; 1651501-2015-00023 AND 1651501-2015-00022. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 6JAN2016. THE INVESTIGATION ACTIVITIES INCLUDED: A REVIEW OF THE MANUFACTURING RECORDS FOR THE SIZE 0 STANDARD LINER, P/N LNR-0960-00S, LOT #QJ0060/ CMR #(B)(4) FOUND THAT ALL APPLICABLE MATERIAL, PROCESS AND FINISHED COMPONENT SPECIFICATIONS WERE SATISFIED. ACCORDING TO SALES DATA FOR RSS FOR 2012-2015 PROVIDED BY MARKETING, THERE HAVE BEEN APPROXIMATELY 613 REVERSE SHOULDER SURGERIES THAT COULD HAVE UTILIZED THE REVERSE BODY/BODY SCREW. (B)(4). CONCLUSION: THE COMPLAINT THAT THE REVERSE BODY WOULD NOT FULLY ACCEPT THE LINER IS NOT CONFIRMED: A LARGE PIECE OF METAL STICKING OUT OF THE SCREW HOLE OF THE BODY WAS REMOVED TO TEST HOW WELL THE BODY AND LINERS INTERLOCKED. ONCE THE METAL SHARD WAS REMOVED FROM THE INSIDE OF THE BODY AND THE LINERS WERE ALIGNED CORRECTLY PRIOR TO IMPACTION, THEY FIT INTO THE BODY AS DESIGNED. THE MISALIGNMENT WAS MOST LIKELY CAUSED BY USER ERROR. MANUFACTURING AND COMPONENT DEFECTS ARE ELIMINATED AS POSSIBLE ROOT CAUSES.

    Description of Event or Problem · 1

    THIS IS THE 2ND OF 3 REPORTS FOR THE SAME EVENT, DIFFERENT PRODUCTS. IT WAS REPORTED THE DEVICE WAS IN CONTACT WITH THE PATIENT; HOWEVER, THERE WAS NO PATIENT INJURY. IN THE CASE WE HAD TO DEVIATE FROM THE GENERAL COURSE OF ACTION WHEN THE POLY INNER WOULD NOT FIT INTO THE SMALL REVERSE BODY WHEN IMPACTED WITH THE MALLET. WE TOOK THAT LINER OUT AND TRIED ANOTHER LINER, IT STILL WOULD NOT FIT IN THE REVERSE BODY SO WE TOOK THE STEM REVERSE BODY CONSTRUCT OUT OF THE HUMERAL CANAL AND PRIED THE REVERSE BODY OFF THE STEM, AND PUT A NEW REVERSE BODY ON THE STEM THEN THE NEXT LINER WE TRIED TO IMPACT INTO THE BODY WENT IN ON THE 1ST STRIKE. A SURGICAL DELAY OF 1 HOUR OCCURRED WITH THIS EVENT. INITIAL COMPLAINT WAS FOR THE REVERSE BODY DEVICE (REPORT 1). AS THE INITIAL INVESTIGATION PROGRESSED, IT WAS DECIDED INVESTIGATIONS WOULD BE OPENED FOR THE LINERS THAT DID NOT FIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520535 LINER STANDARD 0 TITAN SHOULDER SYSTEM KWS ASCENSION ORTHOPEDICS QJ0060

    Patients

    Seq Age Sex Outcome Treatment
    1