BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM ROD

    MDR report key: 5896334 · Received August 23, 2016

    Report

    Report Number
    2520274-2016-14319
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 8, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    NKG
    PMA / PMN Number
    K142838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (4.5MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM ROD, PART NUMBER 04.615.226S, LOT NUMBER H042523). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING THAT THE SCREW WAS UNABLE TO BE INSERTED DUE TO A STRIPPED DRIVE RECESS RESULTING IN A 60 MINUTE SURGICAL DELAY. THE 26MM LONG 4.5MM CANCELLOUS POLYAXIAL SCREW (04.615.226S LOT H042523) IS UTILIZED IN THE SYNAPSE SYSTEM FOR POSTERIOR STABILIZATION OF THE UPPER SPINE. THE SYSTEM ALLOWS FOR STABILIZATION FROM THE OCCIPUT TO THE LOWER SPINE UTILIZING POLYAXIAL SCREWS, CLAMPS/HOOKS AND TITANIUM RODS. SPECIFIC INSTRUCTIONS FOR SCREW INSERTION, INCLUDING SCREWDRIVER CONSTRUCT ASSEMBLY, ARE PROVIDED IN THE ASSOCIATED SYSTEM TECHNIQUE GUIDE. THE RETURNED IMPLANT WAS EXAMINED AND THE COMPLAINT CONDITION WAS CONFIRMED AS THE SCREW BODY¿S DRIVE RECESS WAS FOUND TO BE STRIPPED. ADDITIONAL WITNESS MARKS WERE NOTED ON THE SCREW BODY THREADS CONSISTENT WITH EXPLANATION WITH PLIERS. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED; THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESSIVE TORQUE AND OR THE APPLICATION OF TORQUE WHEN THE SCREWDRIVER SHAFT IS NOT FULLY ENGAGED IN THE DRIVE RECESS. RELEVANT DRAWINGS FOR THE RETURNED IMPLANT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL. THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED IMPLANT¿S LOT NUMBER AND NO NCRS OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED WITH THE LOT NUMBER WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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)(4). IT IS UNCERTAIN IF THE DEVICE REMAINED IN THE PATIENT OR NOT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). 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

    (B)(4). STERILE PART 04.615.226S, LOT H042523: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: FEBRUARY 26, 2016. EXPIRATION DATE: FEBRUARY 28, 2026. NON-STERILE PART 04.615.226Y, LOT H032676: MANUFACTURING LOCATION: (B)(4). MANUFACTURED DATE: FEBRUARY 05, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. 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. STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE TIP OF THE SCREWDRIVER SHAFT IDLED WHILE TRYING TO INSERT A SCREW. THE SURGEON ATTEMPTED SEVERAL TIMES BUT WAS UNABLE TO COMPLETELY INSERT THE SCREW IN THE PATIENT'S BONE. THEN THE SURGEON COULD NOT REMOVE OR INSERT THE SCREW FURTHER SINCE THE SCREWDRIVER SHAFT WAS IDLING IN THE SCREW; IT IS UNKNOWN HOW THIS WAS RESOLVED. THE SURGERY WAS DELAYED FOR SIXTY (60) MINUTES DUE TO THE EVENT. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547700 4.5MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM ROD ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG SYNTHES MONUMENT H042523

    Patients

    Seq Age Sex Outcome Treatment
    1