BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPERT END CAP F/HAN TAN GOLD

    MDR report key: 10877042 · Received November 20, 2020

    Report

    Report Number
    8030965-2020-09112
    Event Type
    Injury
    Date Received
    November 20, 2020
    Report Date
    October 27, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    10886982087133
    PMA / PMN Number
    K051678
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS JNJ REPRESENTATIVE. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE HISTORY LOT. STERILE PART: PART: 04.008.000S, LOT: 6L33688, MANUFACTURING SITE: (B)(4), SUPPLIER: FRÜH VERPACKUNGSTECHNIK AG, RELEASE TO WAREHOUSE DATE: OCT. 18, 2019, EXPIRY DATE: OCT. 01, 2029. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY, A MANUFACTURING RECORD EVALUATION WAS NOT PERFORMED. NON-STERILE PART: PART # 04.008.000, SYNTHES LOT # 10L1314, SUPPLIER LOT # 10L1314, SUPPLIER: JABIL INC. -(B)(4), RELEASE TO WAREHOUSE DATE: SEP 19, 2019. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REVISION SURGERY AROUND 9PM TO REPOSITION THE EXPERT HAN NAIL, EXPERT END CAP, SPIRAL BLADE, AND THREE (3) LOCKING SCREWS. THE ORIGINAL PROCEDURE WAS COMPLETED ON (B)(6) 2020 IN THE AFTERNOON. THE SURGEON ORIGINALLY PLACED THE EXPERT HAN NAIL BUT DIAGNOSTIC IMAGING SHOWED EVIDENCE THAT THE EXPERT HAN NAIL REMAINED EXTRAMEDULLARY IN THE MID-DISTAL THIRD OF THE TIBIA. THIS REQUIRED REVISION SURGERY TO CARRY OUT REPOSITIONING OF THE IMPLANTS. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) EXPERT END CAP F/HAN TAN GOLD. THIS IS REPORT 1 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344473 EXPERT END CAP F/HAN TAN GOLD ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES GMBH 04.008.000S 6L33688 10886982087133

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPERT HAN Ø10 LE CANN L240 TAN LIGHT GR| LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN| LOCKSCR Ø5 L30 F/NAILS TAN LIGHT GREEN| LOCKSCR Ø5 L66 F/NAILS TAN LIGHT GREEN| SPIRAL BLADE F/EXPERT RFN L70 TAN GOLD