BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEED TITAN 15X15X15MM IMPLANT, INSERTER

    MDR report key: 5942955 · Received September 12, 2016

    Report

    Report Number
    1649263-2016-10001
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 24, 2016
    Manufacturer
    BIO MEDICAL ENTERPRISES INC
    Product Code
    JDR
    PMA / PMN Number
    K142292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). PATIENT WEIGHT IS UNKNOWN. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS A SINGLE USE INSTRUMENT. DEVICE HISTORY RECORD REVIEW: PART NUMBER: SE-1515TI, BME PARENT LOT NUMBER: BMESE160119, BME DAUGHTER LOT NUMBER: 1602129014: A NON-CONFORMANCE REPORT WAS GENERATED DURING PRODUCTION THE TITAN SLIDER BEING NON-SYMMETRIC. RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS INVESTIGATED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE ADDITIONALLY REVIEWED: LOT BMESE160119 WAS RELEASED TO THE WAREHOUSE (INVENTORY) ON APRIL 15, 2016. MANUFACTURING WAS COMPLETED ON APRIL 14, 2016. A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS RECEIVED WITH THE STAPLE CONNECTED TO THE INSERTER. THE FORCE REQUIRED TO RELEASE THE SLIDER FROM ITS LOCKED STICK POSITION WAS 13.7 LBS. THE DEVICE UNDER INVESTIGATION PERFORMED WITHIN THE TESTED DESIGN SPECIFICATION. HOWEVER, THE IMPLANT ITSELF REMAINED LOCKED IN THE INSERTION STICK. A BONE BLOCK WAS PREPARED FOR IMPLANT INSERTION BY USING A DRILL GUIDE TIP COMPONENT OF SPEED TITAN SE-1515TI TO DRILL INSERTION HOLES. THE IMPLANT WAS INSERTED AS FAR AS POSSIBLE INTO THE BONE BLOCK; THE INSERTION STICK WAS SUBSEQUENTLY PULLED UPWARDS. THE IMPLANT WAS NOT READILY RELEASED. INSTEAD, A SLIGHT BACK-AND-FORCE TWISTING MOTION (WIGGLING) OF THE INSERTION STICK WAS NEEDED TO RELEASE THE IMPLANT INTO THE BONE. THIS ACTION IS NOT CAPTURED IN THE INSTRUCTIONS FOR USE NOR THE SPEED TITAN TECHNIQUE. NO MANUFACTURING ISSUE WAS IDENTIFIED DURING THE INVESTIGATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. REPORTED CONCOMITANT PART IS CONSIDERED PART OF THE REPORTED DEVICE AND NOT A SEPARATE CONCOMITANT PART. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN FOOT PROCEDURE ON (B)(6) 2016 DURING WHICH THE STAPLE FAILED TO RELEASE FROM THE HANDLE (INSERTER). A NEW PACKAGE WITH INSERTER AND STAPLE WAS OPENED. THE DEVICES WERE USED WITHOUT ANY ISSUES. THERE WAS A SURGICAL DELAY OF A FEW MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: STAPLE (PART SE-1515TI, LOT BME SE 160119, QUANTITY: 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    REPORTED CONCOMITANT PART IS CONSIDERED PART OF THE REPORTED DEVICE AND NOT A SEPARATE CONCOMITANT PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593862 SPEED TITAN 15X15X15MM IMPLANT, INSERTER STAPLE, FIXATION, BONE JDR BIO MEDICAL ENTERPRISES INC BMESE160119

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR STAPLE (SE-1515TI)