BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/RT/88MM-MED-STER

    MDR report key: 9982186 · Received April 21, 2020

    Report

    Report Number
    8030965-2020-02973
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    March 27, 2020
    Report Date
    March 27, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819586369
    PMA / PMN Number
    K120717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1); VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA (PART # 04.211.014S, LOT # 6L54056, QUANTITY 1), VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA (PART # 04.211.016S, LOT # 6L41867, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY LOT: EXPIRY DATE: 01. JAN. 2030. DEVICE HISTORY BATCH: PART: 04.117.004S, LOT: 32P8239, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATA: (B)(4). DEZ. 2019 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SURGERY FOR DISTAL HUMERAL FRACTURE USING VA-DHP AND THE LOCKING SCREW. DURING THE SURGERY, THE SURGEON COULD NOT LOCK THE LOCKING SCREW (16 MM IN LENGTH) WITH THE PLATE. HE TRIED ANOTHER LOCKING SCREW (14 MM IN LENGTH), BUT IT COULD NOT BE LOCKED. THE SURGEON GAVE UP INSERTING THE SCREW INTO THE SCREW HOLE OF THE PLATE BECAUSE HE SUSPECTED THE THREAD PART OF THE HOLE WAS BROKEN. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/RT/88MM-MED-STER THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446764 2.7/3.5 TI VA-LCP POSTLAT DHP- LAT SUPT 4H/RT/88MM-MED-STER PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 32P8239 07611819586369

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - PLATES| UNK - SCREWDRIVERS| UNK - SCREWDRIVERS| UNK - SCREWS: LOCKING| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L14 TA| VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L16 TA