BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE

    MDR report key: 4630719 · Received March 25, 2015

    Report

    Report Number
    3000270450-2015-10071
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    March 10, 2015
    Report Date
    March 10, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    GEA
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: ADDITIONAL DEVICE PRODUCT CODES: LXH, KIH AND MJG. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: (B)(4). 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

    COMPLAINT HANDLING UNIT RECEIVED A MAUDE REPORT FORWARDED FROM HSHS ST ANTHONY'S MEMORIAL HOSPITAL FOR MEDWATCH (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE MAUDE EVENT REPORT IS ATTACHED. APPROX. 2-3MM PIECE LEFT IN THE BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT NEEDED A ONE LEVEL TLIF ON (B)(6) 2015. THE SURGEON USED AN ACCESS KIT 10 GAUGE-DIAMOND TIP/ END-OPENING STERILE (03.804.517S) NEEDLE TO GAIN ACCESS TO L5 PEDICLE. THE BONE WAS VERY HARD. DURING INSERTION, THE NEEDLE BENT AND COULD NOT BE REMOVED. IN THE PROCESS OF TRYING TO REMOVE THE NEEDLE, THE NEEDLE BROKE. AS A RESULT, THE SURGEON HAD TO DRILL THROUGH MORE BONE TO GET A FIRM GRIP ON THE SHAFT OF THE NEEDLE TO PULL IT OUT. WITH DIFFICULTY, THE SURGEON WAS ABLE TO REMOVE SOME PARTS OF THE SHAFT HOWEVER, IT BROKE AGAIN. THE SURGEON PROCEEDED WITH THE CASE LEAVING APPROXIMATELY 30-40MM IN L5. ANOTHER NEEDLE WAS USED AND THE SURGEON SUCCESSFULLY COMPLETED THE CASE BEING CAREFUL NOT TO BEND THE NEEDLE ON THE HARD BONE. A 30 MINUTE SURGICAL DELAY WAS REPORTED. NO PATIENT HARM WAS REPORTED OTHER THAN THE RETAINED NEEDLE FRAGMENT. THERE IS NO PLAN TO REMOVE THE REST OF THE NEEDLE. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199549 ACCESS KIT 10 GAUGE-DIAMOND TIP/END-OPENING-STERILE CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY GEA SYNTHES SELZACH 14H11-1

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention