BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 42MM

    MDR report key: 4997794 · Received August 12, 2015

    Report

    Report Number
    2520274-2015-15179
    Event Type
    Injury
    Date Received
    August 12, 2015
    Report Date
    July 23, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDS
    PMA / PMN Number
    PK072095
    Adverse Event
    Yes
    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 MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 212.118, 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE, LOT NUMBER 8921776). THE PRODUCT WAS RETURNED WITH THE COMPLAINT CONDITION OF ¿POSTOPERATIVE LOOSENING¿ AND WAS RECEIVED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE SCREW WAS VISUAL IN A GOOD CONDITION. AS PREVIOUSLY REPORTED, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT AND NO ABNORMALITIES OR DEVIATIONS WERE DETECTED WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. ALL DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. BASED ON THIS, THE COMPLAINT WAS NOT CONFIRMED AND IS NOT VALID FROM A MANUFACTURING STANDPOINT. NO MANUFACTURING-RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. 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. PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. DEVICE INFORMATION WAS OBTAINED UP RECEIPT OF SUBJECT DEVICE AND REPORTED. DATE OF IMPLANT IS UNKNOWN. (B)(6). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE CONSTRUCT (1 PHILOS PLATE AND 4 SCREWS) CONDITION IS CLEAN AND SHOWS NO VISUAL DEVIATIONS. SLIGHT SCRATCHES ON OUTER SURFACE OF THE PLATE AND ON THE INNER FACE ARE CLEARLY VISIBLE. THE THREAD HOLES SHOW MARKS OF USE, BUT, THE THREADS WERE ALL MEASURABLE. A FUNCTIONAL TEST WAS PERFORMED TO ANALYZE THE PROPER ENGAGEMENT OF THE LOCKING HEAD SCREWS INTO THE LOCKING HOLES OF THE PLATE. THE SCREWS COULD BE ENGAGED AND LOCKED IN THE PLATE HOLES AS INTENDED. THEREFORE, THE FUNCTIONAL TESTING WAS SUCCESSFUL AND NO FUNCTIONAL ISSUE COULD BE IDENTIFIED. IT CANNOT BE DETERMINED WHETHER THE SCREW HAD BEEN TIGHTENED WITH 1.5 NM TORQUE LIMITER ATTACHMENT OR AN AIMING DEVICE WITH OUTER SLEEVE WAS USED AS ADVISED IN THE SURGICAL TECHNIQUE. THE INSTRUMENTS ENSURE THAT THE LOCKING SCREW IS CORRECTLY LOCKED IN THE PLATE AND INSERTED IN THE CORRECT ANGLE. IF THE LOCKING SCREW IS INSERTED IMPROPERLY, THE ANGULAR STABILITY OF THE CONSTRUCT IS REDUCED AND COULD POTENTIALLY LEAD TO BACK OUT OF THE SCREW. THE COMPLAINT SITUATION COULD NOT BE REPLICATED AND THE LIMITED PROVIDED INFORMATION DOES NOT ALLOW IDENTIFYING A FINAL ROOT CAUSE. HOWEVER, THE FUNCTIONAL TEST OF THE LOCKING SCREWS WITH PLATE, USING EQUIVALENT INSTRUMENTS, FOUND THEM TO BE WORKING PROPERLY. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT PROVIDED BY REPORTER. UNKNOWN WHEN DEVICE FAILED. THIS REPORT IS FOR (3) UNKNOWN SCREWS/UNKNOWN LOT NUMBER. ORIGINAL IMPLANT DATE UNKNOWN. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND 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.

    Description of Event or Problem · 1

    ADDITIONAL EVENT INFORMATION AND CLARIFICATION WERE PROVIDED BY THE REPORTER. DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THREE (3) LOCKING SCREWS ASSOCIATED WITH A PHILOS PLATE WERE DISCOVERED TO HAVE MIGRATED (LOOSENED) DURING AN X-RAY REVIEW PERFORMED ON AN UNKNOWN DATE. THE ORIGINAL DATE OF IMPLANT IS UNKNOWN. REVISION SURGERY WAS REQUIRED AND WAS PERFORMED ON (B)(6) 2015. DURING THE REVISION SURGERY, IT WAS NOTED THAT A FOURTH LOCKING SCREW HAD ALSO BECOME LOOSE AND NO LONGER LOCKED. THE PHILOS PLATE AND FOUR LOCKING SCREWS WERE EXPLANTED DURING THE REVISION SURGERY. THIS REPORT IS 1 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS:IT WAS REPORTED THAT A PHILOS PLATE WAS IMPLANTED. THE PATIENT RETURNED TO CLINIC AND UPON AN X-RAY TAKEN, IT WAS SEEN THAT 3 LOCKING SCREWS HAD BECAME LOOSE. REVISION SURGERY TOOK PLACE ON THE 23. JULY, ANOTHER SCREW BECOME LOOSE AND WAS NO LONGER LOCKED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527911 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE RECESS 42MM NAIL,FIXATION,BONE JDS SYNTHES BETTLACH 8921776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention