BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUSSCR SYNAPSE Ø4.5 L30 TAN

    MDR report key: 3170346 · Received June 14, 2013

    Report

    Report Number
    2530088-2013-00927
    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. ADDITIONAL INFORMATION: THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND.

    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. VISUAL INSPECTION OF THE PARTS REVEALED THE HEAD OF THE BONE SCREW, AS WELL AS THE THREAD OF THE BONE SCREW SHOW CLEAR EVIDENCE OF THE IMPLANT BEING FORCEFULLY REMOVED. 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 BUSHING, SMALL RING, FOUND ON THE UNDERSIDE 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 DEFORMATION CAN BE SEEN IN THE MISALIGNMENT OF THE EDGE OF THE RING. THE ABOVE MENTIONED DAMAGES AND DEFORMATIONS TEND TO OCCUR WHEN EXCESSIVE FORCE DURING HANDLING IS PLACED ON THE IMPLANT. THE MEASURING AND CONTROL OF THE IMPLANTS IS NO LONGER POSSIBLE DUE TO THE DAMAGES INVOLVED. THE DESCRIBED EVENT IS NOT EXPLAINABLE 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 1 OF 2 REPORTS FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271028 CANCELLOUSSCR SYNAPSE Ø4.5 L30 TAN KWP SYNTHES BRANDYWINE 6640388

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR