BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH

    MDR report key: 5766701 · Received July 1, 2016

    Report

    Report Number
    2530088-2016-10180
    Event Type
    Malfunction
    Date Received
    July 1, 2016
    Date of Event
    June 16, 2016
    Report Date
    June 16, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    PK100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT NOT PROVIDED FOR REPORTING. ADDITIONAL PRODUCT CODES: MNH, MNI, KWQ, KWP. DEVICE NOT IMPLANTED OR EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. CONCOMITANT MEDICAL DEVICES: 6.0MM TI CANN MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH. 03.632.002, T25 STARDRIVE SHAFT F/MATRIX STANDARD. DEVICE HISTORY RECORDS REV EW WAS CONDUCTED. THE REPORT INDICATES THAT THE: 04.606.640, LOT# 9894534, MANUFACTURE DATE: 4-SEP-2015 REVIEW OF THE DHRS SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE COMPLAINT DEVICE (6.0MM TI CANN MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH, PART NUMBER 04.606.640, LOT NUMBER 7613798, MANUFACTURING DATE FEB 25, 2016). THE COMPLAINT DEVICE WAS RECEIVED AT SYNTHES CUSTOMER QUALITY (CQ) FOR EVALUATION WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2016, A PREASSEMBLED 6MM TITANIUM CANNULATED MATRIX POLYAXIAL SCREW BROKE. THE SURGEON ATTEMPTED TO REDIRECT THE SCREW WITH A SCREWDRIVER AFTER IT WAS THREE FORTH OF THE WAY INTO THE BONE. THE MANEUVER RESULTED IN THE SCREWDRIVER ANGLING INSTEAD OF THE SCREW. WHEN THE SCREWDRIVER ANGLED, IT PUT EXCESSIVE FORCE ON THE POLYAXIAL SCREW HEAD WHICH CAUSED THE RING INSIDE TO FRACTURE AND THE HEAD TO POP OFF¿. THE MATRIX POLYAXIAL SCREW IS PART THE MATRIX SPINE SYSTEM. IT IS AN INSTRUMENT SET DESIGNED TO BE USED WITH THE MATRIX PEDICLE SCREW SYSTEM AND ALLOWS MINIMALLY INVASIVE ROD AND SCREW INSERTION FOR THORACOLUMBAR PEDICLE FIXATION PER THE TECHNIQUE GUIDE. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE, THE COMPLAINT CATEGORY OF ¿BROKEN: INTRAOPERATIVELY¿ IS CONFIRMED. THE PART WAS RETURNED WITH A PORTION OF THE TOP THREAD OF THE SCREW BROKEN FROM THE REST OF THE SCREW; THE BROKEN OFF PORTION WAS RETURNED. A REVIEW OF THE CURRENT DESIGN DRAWING FOR THE SCREW WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. AS PREVIOUSLY REPORTED, THE REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; A POSSIBLE CAUSE COULD AS PER THE COMPLAINT DESCRIPTION: ¿SURGEON ATTEMPTED TO REDIRECT THE SCREW WITH A SCREWDRIVER AFTER IT WAS THREE FORTH OF THE WAY INTO THE BONE. THE MANEUVER RESULTED IN THE SCREWDRIVER ANGLING INSTEAD OF THE SCREW. WHEN THE SCREWDRIVER ANGLED, IT PUT EXCESSIVE FORCE ON THE POLYAXIAL SCREW HEAD WHICH CAUSED THE RING INSIDE TO FRACTURE AND THE HEAD TO POP OFF. 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. THE SUBJECT DEVICE IS CURRENTLY UNDERGOING INVESTIGATION AND THE RESULTS ARE PENDING COMPLETION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE CORRECT SUBJECT DEVICE LOT NUMBER, 7613798. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SUBJECT DEVICE LOT WAS MANUFACTURED AT SYNTHES BRANDYWINE. DATE OF MANUFACTURE IS FEB 25, 2014. 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 DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2016, A PREASSEMBLED 6MM TITANIUM CANNULATED MATRIX POLYAXIAL SCREW BROKE. THE SURGEON ATTEMPTED TO REDIRECT THE SCREW WITH A SCREWDRIVER AFTER IT WAS THREE FORTH OF THE WAY INTO THE BONE. THE MANEUVER RESULTED IN THE SCREWDRIVER ANGLING INSTEAD OF THE SCREW. WHEN THE SCREWDRIVER ANGLED, IT PUT EXCESSIVE FORCE ON THE POLYAXIAL SCREW HEAD WHICH CAUSED THE RING INSIDE TO FRACTURE AND THE HEAD TO POP OFF. SURGEON REMOVED THE SCREW AND RETRIEVED BROKEN HEAD WITHOUT ANY ISSUES. A NEW SCREW WAS IMPLANTED. SURGERY WAS SUCCESSFULLY COMPLETED WITH NO OTHER MEDICAL INTERVENTION REQUIRED. NO FRAGMENTS LEFT IN PATIENT AND NO PATIENT HARM REPORTED. A TEN MINUTES SURGICAL DELAY WAS NOTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT MEDICAL DEVICE: HOLDING SLEEVE -STANDARD FOR MATRIX (PART# 03.632.001, LOT# UNKNOWN, QUANTITY 1), T25 STARDRIVE SHAFT FOR MATRIX (PART# 03.632.002, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419964 6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 7613798

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR