BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE BODY SMALL AND BODY SCREW

    MDR report key: 4834594 · Received June 8, 2015

    Report

    Report Number
    1651501-2015-00015
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Report Date
    May 1, 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

    THIS IS THE 1ST 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: METHODS: -EVALUATION OF ACTUAL DEVICE. -REVIEW OF DEVICE HISTORY RECORDS. -REVIEW OF COMPLAINT HISTORY. RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 14-1809 OF P/N (B)(4) (REVERSE BODY SMALL AND BODY SCREW) REVEALED THAT IT SATISFIED ALL APPLICABLE MANUFACTURING SPECIFICATIONS. NO NON-CONFORMANCES WERE PRESENT AND NO ISSUES WERE IDENTIFIED THAT WOULD CAUSE OR CONTRIBUTE TO THE EVENT. 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. A REVIEW OF COMPLAINT RECORDS FOUND ONE OTHER COMPLAINT FOR A LINER/BODY ALIGNMENT ISSUE THAT OCCURRED DURING SURGERY. THE COMPLAINT RATE = 2/613 X 100% = 0.32%. 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 OF THE REVERSE BODY ARE ELIMINATED AS POSSIBLE ROOT CAUSES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED REVISION OR MEDICAL INTERVENTION WAS REQUIRED. IT WAS REPORTED THE DEVICE WAS IN CONTACT WITH THE PT; HOWEVER, THERE WAS NO PT INJURY. ADD'L INFO REQUESTED AND RECEIVED (B)(6) 2015: IN THE CASE WE HAD TO DEVIATE FROM THE GENERAL COURSE OF ACTION WHEN THE POLY LINER 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367774 REVERSE BODY SMALL AND BODY SCREW TITAN SHOULDER SYSTEM KWS ASCENSION ORTHOPEDICS 14-1809

    Patients

    Seq Age Sex Outcome Treatment
    1