BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE WITH RECESS 18MM

    MDR report key: 5451237 · Received February 22, 2016

    Report

    Report Number
    3009450884-2016-10011
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 1, 2016
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HRS
    PMA / PMN Number
    PK103243
    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. PATIENT INITIALS & DOB NOT PROVIDED BY REPORTER. NOT EXPLANTED. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 23 SEPTEMBER 2015, EXPIRY DATE: 01 SEPTEMBER 2025, 412.818S / LOT 9622695. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD 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

    HOSPITAL CONTACT NUMBER: (B)(6). MANUFACTURING INVESTIGATION EVALUATION: THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER ETCHING WAS READABLE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT WITH NO ABNORMALITIES OR DEVIATIONS DETECTED THAT WOULD LEAD TO THE COMPLAINT FAILURE. ALL DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED. IT WAS NOTED THAT THERE WAS A DEVIATION AT THE THREAD OF THE SCREW HEAD (THE DIAMETER WAS TOO SMALL). BASED ON THIS INFORMATION, THE COMPLAINT IS RATED AS CONFIRMED AND ALSO AS VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. PRODUCT INVESTIGATION SUMMARY: THE RESULTS OF THE MANUFACTURING INVESTIGATION HAVE SHOWN THAT A DEVIATION AT THE THREADED PORTION OF THE SCREW HEAD WAS FOUND (DIAMETER TOO SMALL). THIS IS CLEARLY A MANUFACTURING PROCESS ISSUE WHICH WAS NOT DETECTED DURING THE FINAL INSPECTION. AFTERWARDS, IT IS NOT POSSIBLE TO DEFINE EXACTLY AT WHICH POINT THIS HAPPENED, BUT TO AVOID SUCH AN OCCURRENCE IN THE FUTURE EFFORTS ARE BEING MADE TO PREVENT SUCH AN OCCURRENCE IN THE FUTURE. DEVICE 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

    ADDITIONAL PRODUCT CODE: HWC. (B)(4). AN IMPLANT DATE OF (B)(6) 2016 WAS REPORTED; HOWEVER THE SCREW WAS REPORTEDLY REMOVED AND WAS NOT IMPLANTED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGERY FOR RADIAL HEAD FRACTURE WAS HELD BY USING RADIAL HEAD PLATE (RHP) SET ON (B)(6) 2016. WHILE THE SURGEON APPLIED THE REPORTED SCREW TO PROXIMAL LOCKING HOLE OF THE PLATE, IT WAS NOT LOCKED EVEN THOUGH HE WAS DOING IT FOR A WHILE. HE THEN CHECKED WITH X-RAY AND FOUND THAT THE SCREW WENT THROUGH THE PLATE. HE ALLEGED THAT HE DIDN'T FEEL ANY RESISTANCE. HE ALSO REALIZED THAT THE SCREW HEAD WAS A LITTLE SMALLER THAN THE OTHER REGULAR SCREWS. THE SURGEON COMPLETED THE SURGERY BY REMOVING THE SCREW IN QUESTION AND USED ANOTHER ONE SUCCESSFULLY. THERE WAS 20 MINUTES SURGICAL DELAY. NO PATIENT HARM WAS REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107975 2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE WITH RECESS 18MM PLATE, FIXATION, BONE HRS SYNTHES GRENCHEN 9622695

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention