BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 5140286 · Received October 9, 2015

    Report

    Report Number
    2520274-2015-16514
    Event Type
    Injury
    Date Received
    October 9, 2015
    Date of Event
    March 17, 2015
    Report Date
    September 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    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'S AGE AND DOB NOT PROVIDED BY REPORTER. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT RETURN WAS REPORTED ON THE FIRST SUPPLEMENTAL MEDWATCH. DATE OF RECEIPT ADDED TO THE APPROPRIATE FIELD. (B)(6). (B)(4). PRODUCT INVESTIGATION SUMMARY: RECEIVED PARTS: 1 X 04.111.620S / VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 2HO LOT NUMBER: 8890096, 1 X 04.210.120S / VA LOCKSCR Ø2.4 SELF-TAP L20 TAN LOT NUMBER: UNKNOWN, 2 X 04.210.118S / VA LOCKSCR Ø2.4 SELF-TAP L18 TAN LOT NUMBER: UNKNOWN, 3 X UNKNOWN SCREWS. THE PLATE IN QUESTION SHOWS WEAR AND TEAR SIGNS AND SCRATCHES ALLOVER ON THE SURFACE. THREE (3) SCREWS WERE BROKEN BETWEEN THE SCREW HEAD AND THE THREADED SHAFT. THE TORX-RECESSES OF ALL THREE SCREWS WERE INTACT. THE REMAINDER OF THE RECEIVED SCREWS WAS INTACT, BUT SHOWED SIGNS OF WEAR AND TEAR. THE MANUFACTURING REVIEW OF THE ARTICLES (WITH THE KNOWN LOT NUMBERS) SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WITHOUT THE ORIGINAL LABEL, IT IS IMPOSSIBLE TO DISTINGUISH THE RECEIVED SCREWS. FURTHERMORE, THERE IS NO INFORMATION ABOUT THE CORRESPONDING LOT NUMBERS OF THE SCREWS. THE MICROSCOPIC VIEWS OF THE BROKEN SURFACES SHOW A HOMOGENOUS SURFACE, WHICH INDICATES MATERIAL CONFORMITY. THE MANUFACTURER IS NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT ON THE ARTICLE. ALSO, THERE ARE NOT ANY OTHER COMPLAINTS FOR THIS ARTICLE. BECAUSE OF THE DAMAGE TO THE SCREWS, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY OF THE VALID MANUFACTURING SPECIFICATIONS. BASED ON THE PROVIDED CLINICAL INFORMATION AND THE INVESTIGATION RESULTS, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. MULTIPLE FACTORS CAN LEAD TO TECHNICAL DIFFICULTIES DURING REMOVAL. THESE FACTORS INCLUDE, BUT ARE NOT LIMITED TO: WRONG TORQUE OR ANGULATION OF THE SCREWS DURING INSERTION, OR PROTEINS WHICH ARE FORMING A BOND BETWEEN THE PLATE AND SCREW THREAD. SOME OF THESE FACTORS ARE PATIENT SPECIFIC FACTORS OR THEY DEPEND ON THE PROPER CARE OF THE SURGEON, AND CAN THUS NOT BE INVESTIGATED NOR CONTROLLED BY DEPUY SYNTHES. IT IS CONCLUDED THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. ORIGINAL IMPLANT PROCEDURE TOOK PLACE ON AN UNKNOWN DATE IN (B)(6) 2014. 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

    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 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A RECONSTRUCTION SURGERY TOOK PLACE ON (B)(6) 2015 FOR A PATIENT BEING RUPTURED IN HER FLEXOR TENDON AROUND PLATE IMPLANTATION WHICH TREATED IN (B)(6) 2014. DURING SURGERY OF REMOVING IMPLANTS, THE SURGEON DETECTED THE BREAKAGE OF REPORTED SCREWS AT THEIR HEAD (2X 04.210.118S AND 1X 04.210.120S). ACCORDINGLY HE REMOVED THE SCREWS AND PLATE AND COMPLETED THE RECONSTRUCTION SURGERY SUCCESSFULLY. A PATIENT IS NOW UNDER OBSERVATION. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    CLARIFICATION: PATIENT SUFFERED FLEXOR MUSCLE TENDON TEARING SOMETIME AFTER THE INITIAL IMPLANT PROCEDURE IN (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671590 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention