BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUNT TIP SCREW, 4X42MM

    MDR report key: 9542478 · Received January 3, 2020

    Report

    Report Number
    0009613350-2020-00001
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 11, 2019
    Report Date
    July 29, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    HWC
    UDI-DI
    00889024505452
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    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. ADDITIONAL: H2, H6. CORRECTION: B4, G4, G7, H10. EVENT DESCRIPTION: IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH A ANN PH NAIL ON (B)(6) 2019 AND AFTER THAT THE PROXIMAL SCREW OF ANN HUMERAL WAS FOUND BACKED OUT (MIGRATED). NO REVISION SURGERY DONE YET. THE END CAP (POTENTIALLY: NAIL CAP) WAS TIGHTENED FIRMLY. REVIEW OF RECEIVED DATA: - DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. - X-RAYS: 4 X-RAYS WERE RECEIVED AND REVIEWED BY HCP: ASSESSMENT: FOUR IMAGES OF THE LEFT HUMERUS DEMONSTRATE AN INTRAMEDULLARY ROD WITH TWO DISTAL AND FOUR PROXIMAL INTERLOCKING SCREWS. COMMINUTED FRACTURE OF THE PROXIMAL HUMERAL DIAPHYSIS WITH INVOLVEMENT OF THE GREATER TUBEROSITY. OSTEOPENIA. ON IMAGES ONE AND FOUR, THE SECOND MOST PROXIMAL SCREW THROUGH THE GREATER TUBEROSITY APPEARS TO HAVE PARTIALLY BACKED OUT. INFERIOR SUBLUXATION OF THE HUMERAL HEAD IS PRESENT ON IMAGE FOUR AN IMAGE ONE, POSSIBLY POSITIONAL. IMPRESSIONS: INTRAMEDULLARY ROD WITH PARTIALLY BACKED OUT SECOND-MOST PROXIMAL SCREW THE GREATER TUBEROSITY. COMMINUTED FRACTURE SEEN INVOLVING THE PROXIMAL HUMERAL DIAPHYSIS AND GREATER TUBEROSITY. OVERALL FIT AND ALIGNMENT OF THE IMPLANT IS APPROPRIATE. OSTEOPENIA. NO SIGNS OF LOOSENING. NO CONTRIBUTING FACTORS ARE IDENTIFIED. LUCENT FRACTURE LINE STILL SEEN. ON IMAGES ONE AND TWO, THERE STILL APPEARS TO BE GOOD FIXATION OF THE CORTICAL BONE. - COMMUNICATION WITH TRAUMA DEVELOPMENT: IT WAS CONFIRMED THAT A 2NM TIGHTENING TORQUE HAS BEEN TESTED AND ENSURES THE CORRECT LOCKING OF THE SCREWS. MOREOVER, IT WAS DETERMINED, THAT THE TWO PROXIMAL SCREWS HAVE MIGRATED, WHICH ARE THE SHORTEST ONES. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED AS THEY REMAIN IMPLANTED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 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 (B)(6) 2019 AND AFTER THAT THE PROXIMAL SCREW OF ANN HUMERAL WAS FOUND BACKED OUT (MIGRATED). NO REVISION SURGERY DONE YET. THE END CAP (POTENTIALLY: NAIL CAP) WAS TIGHTENED FIRMLY. BASED ON THE EVALUATION OF THE RECEIVED X-RAYS, THE REPORTED EVENT CAN BE CONFIRMED. 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). NO X-RAYS SHOWING THE SITUATION DIRECTLY AFTER IMPLANTATION HAVE BEEN RECEIVED, THEREFORE THE CORRECT IMPLANTATION OF THE SCREWS CANNOT BE ASSESSED. MOREOVER, PATIENT MEDICAL DETAILS (BONE DENSITY, ACTIVITY LEVEL, RELEVANT MEDICAL HISTORY) REMAIN UNKNOWN. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREWS. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2019-00820. 0009613350-2019-00816. 0009613350-2020-00001. 0009613350-2020-00002.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: BLUNT TIP SCREW, 4X36MM; CATALOG# : 47248603640; LOT# : 3006509. BLUNT TIP SCREW, 4X40MM; CATALOG# : 47248604040; LOT# : 3006457. BLUNT TIP SCREW, 4X56MM; CATALOG# : 47248605640; LOT# : 2981226. CORTICAL BONE SCREW, 4X24MM; CATALOG# : 47248612440; LOT# : 2989736. CORTICAL BONE SCREW, 4X26MM; CATALOG# : 47248612640; LOT# : 2981200. PROXIMAL HUMERUS NAIL CAP, 0MM; CATALOG# : 47248801000; LOT# : 3004572. HUMERUS BALL NOSE GUIDEWIRE, STERILE; CATALOG# : 110035668; LOT# : 2999951. UNKNOWN; CATALOG# : DB33330A; LOT# : 190801. KIRSCHNER WIRE WITH TROCAR TIP, 2.5 MM, 280 MM; CATALOG# : 29025280; LOT# : 4503176237. SOLIDLOK HEX TIP 3.5MM; CATALOG# : 281001019; LOT# : 742720. PROXIMAL HUMERUS, LEFT, 11X160MM; CATALOG# : 47249616111; LOT# : 2981136. PROXIMAL HUMERUS NAIL CAP, 11X2.5MM; CATALOG# : 47248801102; LOT# : 2981238. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND A REVISION SURGERY IS YET TO TAKE PLACE FOR THE MIGRATION OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9440 BLUNT TIP SCREW, 4X42MM BLUNT TIP SCREW HWC ZIMMER GMBH N/A 2981219 00889024505452

    Patients

    Seq Age Sex Outcome Treatment
    1