BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANN BLUNT TIP SCREW 4X44MM

    MDR report key: 15976372 · Received December 14, 2022

    Report

    Report Number
    0009613350-2022-00646
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 2, 2022
    Report Date
    December 14, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024505469
    PMA / PMN Number
    K181827
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL DEVICES: PROXIMAL HUMERUS, RIGHT, 9X160MM; ITEM# 47-2496-160-09; LOT# 3079661. ANN BLUNT TIP SCREW 4X44MM; ITEM# 47-2486-044-40; LOT# 3076741. ANN BLUNT TIP SCREW 4X44MM; ITEM# 47-2486-044-40; LOT# 3076742. ANN BLUNT TIP SCREW 4X54MM; ITEM# 47-2486-054-40; LOT# 3024756. ANN CORT BONE SCREW 4 X 28MM; ITEM# 47-2486-128-40; LOT# 3091558. ANN CORT BONE SCREW 4 X 32MM; ITEM# 47-2486-132-40; LOT# 3068973. AFFIXUS PH NL CAP 0MM; ITEM# 47-2488-010-00; LOT# 3091320. TORQUE LIMITING HANDLE; ITEM# 27923; LOT# UNKNOWN. REPORT SOURCE ¿ FOREIGN: JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350 - 2022 ¿ 00615, 0009613350 - 2022 ¿ 00644, 0009613350 - 2022 ¿ 00645. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED: PRODUCT EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE MANUFACTURING RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. DEVICES USED FOR TREATMENT. ONE UNDATED X-RAY IMAGE OF THE AFFECTED HUMERUS WAS RECEIVED AND REVIEWED. THE RECEIVED X-RAYS SHOWS WHAT APPEARS TO BE THE MOST PROXIMAL SCREW HAVING MIGRATED. HOWEVER, AS NO FURTHER X-RAY IMAGES WERE RECEIVED, NO COMPARISON OR FURTHER ASSESSMENT CAN BE MADE REGARDING THE MIGRATION OF THIS SCREW. BASED ON THE INVESTIGATION IT COULD BE ASSUMED THAT FURTHER POSSIBLE CONTRIBUTING FACTORS TO THE MIGRATION OF THE SCREW MIGHT BE MULTIFACTORIAL RELATED TO EITHER PATIENT CONDITION, BEHAVIOR OR IMPLANTATION PROCEDURE. IF AND TO WHAT EXTENT ANY OF THESE ASPECTS MAY HAVE INFLUENCED THE MIGRATION OF THE SCREW REMAINS UNKNOWN. AN ADDITIONAL DEEPER INVESTIGATION WAS PERFORMED WHICH IDENTIFIED THE DESIGN LIMITATION OF THE LOCKING MECHANISM OF THE NAIL AS A POTENTIAL CONTRIBUTING FACTOR. AS PART OF THE DEEPER INVESTIGATION, A SCIENTIFIC LITERATURE SEARCH WAS CONDUCTED AND A SYSTEMATIC REVIEW OF THE OUTCOME OF INTRAMEDULLARY NAILING FOR ACUTE PROXIMAL HUMERUS FRACTURE SHOWED THAT SCREW MIGRATION AND PERFORATION INTO THE JOINT IS THE SECOND MOST COMMON COMPLICATION FOLLOWING SECONDARY LOSS OF REDUCTION. IN ADDITION, SCIENTIFIC LITERATURE OF COMPETITOR AND PREDICATE DEVICES WERE ASSESSED. THIS REVIEW HAS SHOWN THAT THE NAIL SYSTEM PERFORMS BETTER AND/OR IN EQUAL RANGE IN COMPARISON WITH LEGALLY MARKETED SIMILAR DEVICES. THEREFORE, NO DESIGN CHANGES WERE CONDUCTED. IN CONCLUSION, AS THE CAUSE MAY BE MULTIFACTORIAL AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE MIGRATION OF THE SCREW. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A SHOULDER SURGERY AND APPROXIMATELY AFTER 2 MONTHS A REVISION SURGERY WAS PERFORMED DUE TO A BACKED OUT SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022766 ANN BLUNT TIP SCREW 4X44MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3076788 00889024505469

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R