BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEED TITAN 20X20X20MM IMPLANT

    MDR report key: 6401993 · Received March 14, 2017

    Report

    Report Number
    1649263-2017-10003
    Event Type
    Injury
    Date Received
    March 14, 2017
    Report Date
    February 16, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY RECORD REVIEW AND MANUFACTURING INVESTIGATION WERE PERFORMED FOR THE SUBJECT DEVICE. IT MUST BE NOTED THAT THE SUBJECT DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL INVESTIGATION. IT WAS REPORTED THAT ONE (1) SE-2020TI SPEED TITAN STAPLE BROKE POSTOPERATIVELY. TWO (2) OF THE SAME IMPLANT WERE USED BUT IT IS UNCERTAIN AS TO WHICH LOT (BMESE160373 OR BMESE155337) IS ASSOCIATED WITH THE BROKEN DEVICE. THE PHYSICAL PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE COMPLAINT WAS ABLE TO BE CONFIRMED BY CUSTOMER QUALITY THROUGH THE PROVIDED X-RAYS AS IT IS CLEARLY EVIDENT THAT ONE OF THE STAPLE¿S LEG WAS BROKEN. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOWED THAT THERE WERE ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT COULD HAVE POSSIBLY CONTRIBUTED TO THE COMPLAINT. A NONCONFORMANCE RECORD WAS GENERATED DURING PRODUCTION FOR LOT # 1510129112 DURING VISUAL INSPECTION FOR FOUR (4) IMPLANTS THAT HAD MISCUT BARBS. OF THE 64 UNITS IN THE LOT, ALL WERE INSPECTED AND FOUR (4) UNITS FAILED. THE FOUR (4) NONCONFORMING UNITS WERE SCRAPPED. AS SUCH, THE NON-CONFORMANCE SHOULD NOT BE RELEVANT TO THIS PARTICULAR COMPLAINT HOWEVER A DETAILED ANALYSIS COULD NOT BE RETURNED WITHOUT THE PHYSICAL PRODUCT. A NONCONFORMANCE RECORD WAS GENERATED DURING PRODUCTION FOR LOT BMESE160373 DURING POST-STERILIZATION INSPECTION FOR TWO (2) IMPLANTS THAT WERE ¿TOED IN¿ (COMPRESSED). THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION SINCE THIS COMPLAINT IS FOR A BROKEN IMPLANT POST-OP AND THE NCMR IS FOR IMPLANTS COMPRESSING IN THE PACKAGE. A ROOT CAUSE COULD NOT BE DETERMINED WITHOUT RECEIPT OF THE PRODUCT. NO FURTHER INVESTIGATION COULD BE PERFORMED AS THE PHYSICAL PRODUCT WAS NOT RETURNED. 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

    (B)(6). REPORTEDLY SIX WEEK PRIOR TO BREAKAGE BEING NOTICED. UNKNOWN IF/WHEN DEVICE WAS EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    PATIENT ID: (B)(6); DEVICE HAS NOT BEEN REPORTED AS EXPLANTED. UDI: (B)(4). IT IS UNKNOWN WHICH OF THE TWO IMPLANTED DEVICE BROKE. BOTH DEVICES HAD THE SAME PART NUMBER. IT IS UNKNOWN IF LOT BMESE155337 OR LOT BMESE160373 IS THE BROKEN DEVICE. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 AT A 6-WEEK FOLLOW UP APPOINTMENT IT WAS NOTED THAT A BME STAPLE HAD BROKEN POSTOPERATIVELY; THERE WAS LOSS OF REDUCTION AND THERE WAS DORSIFLEXION THROUGH THE FUSION SITE. THE JOINT HAD BEEN REDUCED AND HELD WITH WIRES. THE POST-OPERATIVE PROTOCOL WAS AN AO SPLINT AND THEN CAM BOOT WITH NIGHT BOOT. THIS REPORT IS FOR AN UNKNOWN BME STAPLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    TWO OF THE SAME BME STAPLE IMPLANTS WERE USED IN THE SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY WAS COMPLETED SUCCESSFULLY, WITH NO REPORTED SURGICAL DELAY. THE PATIENT WAS REPORTEDLY STABLE DURING AND FOLLOWING THE SURGERY. AT A SIX-WEEK POSTOPERATIVE FOLLOW-UP APPOINTMENT WITH THE SURGEON ON (B)(6) 2017, X-RAYS IDENTIFIED THAT ONE OF THE STAPLES HAD BROKEN POSTOPERATIVELY. IT IS UNKNOWN WHICH ONE WAS BROKEN. THE STAPLES REMAIN IMPLANTED, WITH NO KNOWN REVISION SURGERY SCHEDULED. CONCOMITANT DEVICE: BME DRILL KIT (PART DK-265-S, LOT BMEDK160032, QUANTITY 1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186139 SPEED TITAN 20X20X20MM IMPLANT BONE STAPLE JDR BIO MEDICAL ENTERPRISES INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention