BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DST-RAD PL 6H HD/2H SHAFT/RT-STER

    MDR report key: 5141722 · Received October 9, 2015

    Report

    Report Number
    1000562954-2015-10188
    Event Type
    Injury
    Date Received
    October 9, 2015
    Date of Event
    March 17, 2015
    Report Date
    September 28, 2015
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK083694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. 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. 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. CORRECTED DATA: DATE OF POST-OPERATIVE EVENT IS UNKNOWN. 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

    ADDITIONAL NARRATIVE: 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.

    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. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 21. MARCH 2014, EXPIRY DATE: 01. MARCH 2024, NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

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

    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 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671743 2.4MM TI VA-LCP 2-CLMN VLR DST-RAD PL 6H HD/2H SHAFT/RT-STER PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 8890096

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention