BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDTITAN COMPRESSION IMPLANT KIT 20X20X20MM

    MDR report key: 6756928 · Received August 1, 2017

    Report

    Report Number
    1649263-2017-10016
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    July 3, 2017
    Report Date
    July 3, 2017
    Manufacturer
    BIO MEDICAL ENTERPRISES INC
    Product Code
    JDR
    PMA / PMN Number
    K142292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE OR DATE OF BIRTH AND WEIGHT NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW. PART NUMBER: SE-2020TI, BME LOT NUMBER: BMESE160070, LOT EXPIRATION DATE: 22 FEB 2021, MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 15 MAR 2016. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NC, NO RELEVANCE TO COMPLAINT CONDITION DHR REVIEW (PARENT LOT). PART NUMBER: SE-2020TI, BME LOT NUMBER: 16001129006, MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 16 FEB 2016. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NC, NO RELEVANCE TO COMPLAINT CONDITION DHR REVIEW (PARENT LOT). PART NUMBER: SE-2020TI , BME LOT NUMBER: 16001129007, MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 16 FEB 2016. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 STAPLE MALFUNCTIONED DURING A RIGHT FIRST METATARSAL MODIFIED MCBRIDE BUNION REPAIR ON (B)(6) 2017. THE SURGEON INSERTED THE FIRST STAPLE AND ACHIEVED THE DESIRED COMPRESSION. AFTER A SECOND STAPLE WAS INSERTED AND COMPRESSED, X-RAYS WERE TAKEN TO CONFIRM PLACEMENT. EVERYTHING THEN DISTRACTED, A GAP WAS PRESENT IN BETWEEN THE JOINT. THE SURGEON THEN HAD TO REMOVE THE SECOND STAPLE. ANOTHER SMALLER SIZE WAS CHOSEN FOR THE NEXT ATTEMPT. WHILE DRILLING, THE SURGEON HIT THE FIRST STAPLE, SO WASN¿T ABLE TO INSERT THE SMALLER SIZE SECOND STAPLE. BECAUSE OF THE LOSS OF COMPRESSION WHICH REQUIRED REMOVAL OF THE SECOND STAPLE, THE ORIGINAL ¿MAPPED¿ LOCATION FOR THE SECOND STAPLE WAS LOST. A DIFFERENT LOCATION HAD TO BE CHOSEN, AND THE SURGEON WAS HITTING THE FIRST STAPLE UPON DRILLING. A DECISION WAS MADE TO ABORT THE EFFORT. ONLY ONE STAPLE WAS LEFT IMPLANTED. THE SURGEON USED A 4.0 CANNULATED SCREW INSTEAD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) SPEEDTITAN COMPRESSION IMPLANT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536990 SPEEDTITAN COMPRESSION IMPLANT KIT 20X20X20MM BONE STAPLE JDR BIO MEDICAL ENTERPRISES INC BMESE160070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention