BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUSSCR SYNAPSE Ø4.5 L32 TAN

    MDR report key: 3170329 · Received June 14, 2013

    Report

    Report Number
    2530088-2013-00928
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    October 26, 2011
    Report Date
    November 4, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWP
    PMA / PMN Number
    K091689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE SCREW HEAD AND BONE SCREW ARE INTACT. WHILE IMPLANTING THE SCREW THE SURGEON HEARD A GRATING SOUND AND DECIDED TO SWAP THE SCREW FOR ANOTHER ONE. THE VISUAL OF THIS SCREW REVEALED EVIDENCE OF EXCESS FORCE BEING APPLIED. THE BUSHING FOUND ON THE UNDER-SIDE OF THE POLYAXIAL SCREW HEAD CAN NO LONGER BE ROTATED AS IT HAS BEEN DEFORMED, GENERALLY OCCURRING DUE TO A LARGE AMOUNT OF EXCESS FORCE BEING APPLIED. THE SCREWDRIVER RECESS IN THE BONE SCREW IS CLEARLY WORN THROUGH. THIS COULD HAVE OCCURRED DUE TO THE SCREWDRIVER NOT BEING PROPERLY INSERTED. IT IS NOT POSSIBLE TO DEFINE WHETHER THIS WEAR OCCURRED WHILE INSERTING THE IMPLANT, OR REMOVING IT. THE DEFORMATION, WHICH CAN BE SEEN ON THE BONE SCREW, LEADS TO THE ASSUMPTION THAT, WHILE IMPLANTING THE ITEM THE SCREWDRIVER WAS NOT CORRECTLY ATTACHED TO THE SCREW. SUCH AN EVENT COULD LEAD TO A GRATING SOUND BEING HEARD; AS WELL AS THE EXPLAINED DEFORMATION. IT IS, HOWEVER, NOT POSSIBLE TO DRAW FINAL CONCLUSIONS BASED ON THE INFORMATION PRESENTED. THIS COMPLAINT HAS BEEN DETERMINED TO BE INDETERMINATE.

    Description of Event or Problem · 1

    THE DOCTOR WAS USING SYNAPSE FOR A POSTERIOR FUSION FROM C4-T1. THE PATIENT HAS A NON-SYNTHES ANTERIOR PLATE AND SCREWS AT LEVELS C4-6 ON BOTH SIDES AND A PEDICLE SCREW IN AT C7 ON THE PATIENTS LEFT SIDE. AS HE WAS INSERTING A SCREW AT T1 ON THE PATIENTS LEFT HE SEEMED TO BE HAVING TROUBLE INSERTING THE SCREW. IT LOOKED LIKE THE SCREWDRIVER WAS NOT ENGAGED IN THE BONE SCREW AS THE TULIP HEAD WAS TURNING, BUT THE BONE SCREW WAS NOT GOING INTO THE PEDICLE. HE WAS ASKED TO REMOVE THE SCREW AND THE SCRUB NURSE RELOADED THE SAME SCREW ON THE SCREWDRIVER, MAKING SURE IT WAS LOADED PROPERLY. AS HE WAS INSERTING THE SCREW, HE REPORTED THAT THE SCREW HEAD HAD DETACHED FROM THE BONE SCREW WHILE HE WAS INSERTING IT. HE REMOVED THE TULIP HEAD AND THEN THE BONE SCREW FROM THE PATIENT BEFORE INSERTING ANOTHER SCREW INTO THE PEDICLE AT T1 ON THE LEFT HAND SIDE. HE THEN PROCEEDED TO INSERT A SCREW INTO THE T1 PEDICLE ON THE PATIENTS RIGHT SIDE. AS HE DID THE SCREW STARTED TO REPORTEDLY SQUEAK. HE SAID HE THOUGHT THE SCREW THAT HAD BROKEN WAS MAKING A SIMILAR NOISE BEFORE IT HAD BROKEN. IT WAS RECOMMENDED THAT HE REMOVE THE SCREW AND THE SCRUB NURSE LOADED ANOTHER SCREW. HE HAD NO TROUBLE INSERTING THAT SCREW. THIS IS 2 OF 2 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270398 CANCELLOUSSCR SYNAPSE Ø4.5 L32 TAN KWP SYNTHES BRANDYWINE 6640389

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR