BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 5554134 · Received April 7, 2016

    Report

    Report Number
    2520274-2016-11981
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    November 29, 2015
    Report Date
    March 15, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING EVALUATION WAS COMPLETED: THIRTY (30) SCHANZ SCREWS WERE RECEIVED FOR INVESTIGATION. THE INVESTIGATION OF THE COMPLAINED ARTICLE SHOWS THAT INDEED THE COUPLING SHAFT IS OUT OF SPECIFICATIONS. ONE CYCLE DURING THE MANUFACTURING PROCESS WAS NOT CARRIED OUT AS INTENDED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS REPORT IS FOR THE FIRST UNKNOWN SCREW WHICH REPORTEDLY BECAME STUCK IN THE FRACTURE CLAMP. THE PART AND LOT NUMBER OF THIS SCREW WERE NOT SPECIFIED BY THE REPORTER. THE FOLLOWING SCREWS WERE REPORTED/RECEIVED BY THE MANUFACTURER FOR EVALUATION: QTY: 4, 6.2MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM, PART NUMBER 496.723-EXS, LOT 8030146, DEVICE PRODUCT CODE¿KWP, COMMON NAME¿APPLIANCE, FIXATION, SPINAL INTERLAMINAL, ADDITIONAL DEVICE PRODUCT CODES¿NKB, MNI, MNH, AND KWQ. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). QTY 1, 6.2MM TI SCHANZ SCREW WITH DUAL CORE 50MM THREAD/190MM, PART NUMBER 496.723-EXS, LOT 8054416, DEVICE PRODUCT CODE¿KWP, COMMON NAME¿APPLIANCE, FIXATION, SPINAL INTERLAMINAL, ADDITIONAL DEVICE PRODUCT CODES¿NKB, MNI, MNH, AND KWQ. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). (NOT RECEIVED BY MANUFACTURER). QTY 7, 6.2MM TI SCHANZ SCREW WITH DUAL CORE 55MM THREAD/200MM, PART NUMBER 496.725-EXS, LOT 8030697, DEVICE PRODUCT CODE¿KWP, COMMON NAME¿APPLIANCE, FIXATION, SPINAL INTERLAMINAL, ADDITIONAL DEVICE PRODUCT CODES¿NKB, MNI, MNH, AND KWQ. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). QTY 19, 6.2MM TI SCHANZ SCREW WITH DUAL CORE 55MM THREAD/200MM, PART NUMBER 496.725-EXS, LOT 8044689, DEVICE PRODUCT CODE¿KWP, COMMON NAME¿APPLIANCE, FIXATION, SPINAL INTERLAMINAL, ADDITIONAL DEVICE PRODUCT CODES¿NKB, MNI, MNH, AND KWQ. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE KNOWN SUBJECT DEVICE LOTS. THE REVIEWS 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 LOTS. PART: 496.723-EXS - 8030146, MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 23.AUG.2012. PART: 496.723-EXS - 8054416, MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 03.SEP.2012. PART: 496.725-EXS - 8030697, MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 03.SEP.2012. PART: 496.725-EXS - 8044689, MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 03.SEP.2012. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS; HOWEVER, IT IS UNKNOWN AT THIS TIME WHICH OF THE RECEIVED DEVICES IS THE SCREW ADDRESSED IN THIS REPORT. ADDITIONAL INFORMATION WILL BE REPORTED WHEN THE INVESTIGATION COMPLETE. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE INITIAL FRACTURE FIXATION SPINAL PROCEDURE, THE FRACTURE CLAMP STUCK TO THE UPPER PART OF THE UNKNOWN SCREW, WAS NOT PASSING, AND COULD NOT BE DETACHED. THE SURGEON HAD TO REMOVE THE INSERTED UNKNOWN SCREW AND CLAMP. PRIOR TO INSERTING A NEW CLAMP AND SCREW, SURGICAL PERSONNEL CHECKED THE DEVICES OUTSIDE OF THE OPERATING ROOM. THE SURGICAL PERSONNEL USED A SECOND CLAMP AND CHECKED IT WITH 29 MORE SCREWS BEFORE ONE WAS FOUND TO WORK CORRECTLY WITH THE CLAMP. IT IS UNKNOWN WHY 29 MORE SCREWS WERE USED AND WHAT THE MALFUNCTION WAS WITH THOSE 29 SCREWS. THE SURGEON THEN INSERTED THE SECOND CLAMP AND AN UNKNOWN SCREW SUCCESSFULLY AND WAS ABLE TO COMPLETE THE PROCEDURE. THERE WAS A ONE HOUR SURGICAL DELAY DUE TO PROCURING A REPLACEMENT CLAMP AND SCREW. THIS REPORT IS FOR THE FIRST UNKNOWN SCREW WHICH REPORTEDLY BECAME STUCK IN THE FRACTURE CLAMP. THIS REPORT IS 3 OF 33 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209390 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention