BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 70MM

    MDR report key: 3162542 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-03316
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS INTENDED FOR TREATMENT, NOT DIAGNOSIS. A REVISION SURGERY TOOK PLACE (B)(6) 2013. THE PLATE AND 3 SCREWS WERE ALL RETRIEVED AND THE REVISION OPEN REDUCTION INTERNAL FIXATION WENT SMOOTHLY. THE FINAL FIXATION WAS DONE WITH A 4.5MM LOCKING COMPRESSION PROXIMAL FEMORAL PLATE. THE PATIENT IS RECOVERING WELL.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTED DATE OF IMPLANT WAS IN 2012 (DATE UNKNOWN). IT WAS REPORTED A REVISION SURGERY IS SCHEDULED FOR THE WEEK OF (B)(6) 2013, UNKNOWN IF DEVICE(S) WERE REMOVED. 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.

    Additional Manufacturer Narrative · 1

    ONE PIECE OF A PEDIATRIC LCP PLATE WAS RECEIVED ALONG WITH ONE 212.214 AND TWO 212.224 5MM SELF-TAPPING LOCKING SCREWS. THE THREE SCREWS WERE RECEIVED WITH THE HEADS BROKEN OFF AND RADIAL AND AXIAL DAMAGE TO THE THREADED LENGTHS OF EACH. CONFIGURATION, DIMENSIONAL INTEGRITY AND MATERIAL MEET THE SPECIFICATIONS OF THEIR RESPECTIVE DRAWINGS. THE PROXIMAL TWO LOCKING SCREW HOLES SHOW SIGNIFICANT ELONGATION WITH SHARP EDGES AND BURRS CREATED ON THE DISTAL INSIDE EDGE OF THE MOST PROXIMAL LOCKING SCREW HOLES AND ON THE PROXIMAL OUTSIDE EDGE OF THE MOST PROXIMAL LOCKING SCREW HOLES. THIS CONDITION IS LIKELY TO BE FROM THE PROXIMAL LOCKING SCREWS BEING DRILLED, INSERTED AND /OR POSITIONED AT AN EXTREME ANGLE CONTRARY TO THAT PERMITTED BY PLATE''S HOLE ANGLE. VARIABLE ANGULATION OF THE SCREW TO THE PLATE'S FEATURES IS NOT AN OPTION WITH THIS SYSTEM. AT SUCH AN EXTREME ANGLE IT IS UNLIKELY THAT ANY SIGNIFICANT LOCKING OF THE SCREW HEADS INTO THE PLATE'S LOCKING FEATURE WAS EVER ACHIEVED AS WELL. WHETHER EFFECTIVE DRILL GUIDE PLACEMENT WAS EMPLOYED IS DOUBTFUL AS EVIDENCED BY THE DAMAGE TO THE PLATE AND COULD HAVE CONTRIBUTED TO THE ISSUE. IT IS ALSO POSSIBLE THAT THE 150 DEGREE PLATE APPLICATION WITH RELATIONSHIP TO THE ANATOMY WAS A CONTRIBUTING FACTOR AS WELL AS ABSENCE OF EXTERNAL SPLINT AND ALL AS RECOMMENDED IN THE PEDIATRIC LCP PLATE SYSTEM TECHNIQUE GUIDE. IT IS IMPORTANT TO NOTE THAT THE FINAL REVISION FIXATION WAS DONE WITH A 4.5MM LCP PROXIMAL FEMORAL PLATE AND THE PATIENT IS RECOVERING WELL. RISK ASSESSMENT PROVIDES CAUSE AS: NON-COMPLIANT PATIENT, EARLY EXCESSIVE STRAIN BY THE PATIENT AND USER ERROR: IMPROPER TECHNIQUE, IMPROPER SCREW SELECTION AS WELL. THE CONDITION OF THE RETURNED DEVICE INDICATES THAT IT WAS SUBJECTED TO FORCES IN EXCESS OF THAT REQUIRED FOR ITS INTENDED USE AND CONTRARY TO THE RECOMMENDED METHOD OF USE DEFINED IN THE TECHNIQUE GUIDE. THE DESIGN OF THE PLATE AND SCREW SYSTEM WAS EVALUATED AND IS ADEQUATE FOR ITS INTENDED USE. INCORRECT CATALOG NUMBER PROVIDED ON INITIAL REPORT.

    Description of Event or Problem · 1

    SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: PATIENT UNDERWENT RIGHT VALGUS HIP OSTEOTOMY IN 2012 (DATE UNKNOWN) WAS IMPLANTED WITH PEDIATRIC LCP HIP PLATE AND SCREW CONSTRUCT. REPORTEDLY THE PATIENT HAD A NON-UNION. IT WAS REPORTED THE PLATE LOOKS INTACT; HOWEVER, TWO OR THREE OF THE LOCKING SCREWS IN THE HEAD OF THE PLATE APPEAR TO BE BROKEN. THE PATIENT IS ASYMPTOMATIC. A REVISION SURGERY WAS SCHEDULED FOR THE WEEK OF (B)(6) 2013. THIS IS 2 OF 4 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263382 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 70MM KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention