BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW 4X46MM

    MDR report key: 9599627 · Received January 17, 2020

    Report

    Report Number
    0009613350-2020-00025
    Event Type
    Injury
    Date Received
    January 17, 2020
    Date of Event
    December 5, 2019
    Report Date
    June 23, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HWC
    UDI-DI
    00889024505476
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED AGAIN. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A ANN PH NAIL ON NOV 11, 2019. AFTER INITIAL SURGERY, THE PROXIMAL SCREW OF ANN HUMERAL WAS FOUND BACKED OUT. CORELOCK WAS TIGHTENED FIRMLY IN THE INITIAL PROCEDURE. REVISION TOOK PLACE ON DEC 5 2019. REVIEW OF RECEIVED DATA: - X-RAYS: 1 X-RAY DATED NOV 28, 2019 AND A SECOND UNDATED "PRE-REVISION" X-RAY WERE RECEIVED AND REVIEWED BY HCP: SUMMARY OF IMAGING: AP RIGHT HUMERUS DATED 11/28/19, AP RIGHT HUMERUS LABELED "PRE-REVISION" ASSESSMENT OF IMAGING: INITIAL AP VIEW DEMONSTRATES INTRAMEDULLARY NAIL AND SCREW FIXATION TRAVERSING A HUMERAL SHAFT FRACTURE WITH SLIGHT OFFSET AT THE FRACTURE SITE. IMAGE 2 DEMONSTRATES INTERVAL BACKING OUT OF ONE OF THE TWO PROXIMAL HUMERAL SCREWS. THERE IS NO HARDWARE FRACTURE. THERE IS NO CHANGE IN FRACTURE ALIGNMENT. IMPRESSIONS: INTERVAL BACKING OUT OF ONE OF THE TWO PROXIMAL HUMERAL FIXATION SCREWS. NO CHANGE IN FRACTURE ALIGNMENT. OVERALL FIT AND ALIGNMENT IS ANATOMIC ON BOTH IMAGES. BONE QUALITY IS OSTEOPENIC. THERE IS NO RADIOGRAPHIC EVIDENCE OF INTERVAL TRAUMA. PRODUCT EVALUATION: - VISUAL EXAMINATION: THE EXPLANTED SCREW HAS BEEN RECEIVED FOR AN INVESTIGATION. THERE ARE SOME DEFORMATIONS ALONG THE THREADS. NO OTHER CONSPICUOUSNESS FOUND. REVIEW OF PRODUCT DOCUMENTATION: - DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. - DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. CONCLUSION: IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A ANN PH NAIL ON NOV 11, 2019. AFTER INITIAL SURGERY, THE PROXIMAL SCREW OF ANN HUMERAL WAS FOUND BACKED OUT. IT WAS FURTHER REPORTED, THAT THE CORELOCK WAS TIGHTENED FIRMLY IN THE INITIAL PROCEDURE. REVISION TOOK PLACE ON DEC 5 2019. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE EVALUATION OF THE RECEIVED X-RAYS, THE REPORTED EVENT CAN BE CONFIRMED. THERE WAS A BACKING OUT OF ONE OF THE TWO PROXIMAL HUMERAL FIXATION SCREWS. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION AND BEHAVIOR, IMPLANTATION PROCEDURE OR DESIGN FEATURES. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE BACKING OUT OF THE SCREW REMAINS UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW.

    Description of Event or Problem · 0

    SURGEON'S NAME WAS MADE AVAILABLE.

    Description of Event or Problem · 0

    INVESTIGATION RESULT IS AVAILABLE NOW.

    Additional Manufacturer Narrative · 1

    X-RAYS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION DUE TO MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66504 BLUNT TIP SCREW 4X46MM BLUNT TIP SCREW HWC ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2981221 OR 2989722 00889024505476

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R