MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 18MM VAL NEAR CORTEX SCREW, TI; BONE FIXATION PLATE

Model Number	2.4 X 18MM VAL NEAR CORTEX SCREW, TI
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.The locking thread was found to be damaged but the device was able to thread in and lock in a plate sample without difficulty.
Event or Problem Description
On 1/24/2022, it was reported by a sales representative via email that an ar-8916vnc-18 low profile locking screw was inserted into the plate but it would not lock into place and could be easily removed with little efforts.Surgeon thought the threads on the screw were either warped or worn.Case was completed using another ar-8916vnc-18 from a different lot number.This was discovered during distal radius fracture procedure on (b)(6) 2022.Additional information received: 1/26/2022: the implant did not break in any fashion and all other devices were implanted successfully exhibiting a strong repair.

• Brand Name: 2.4 X 18MM VAL NEAR CORTEX SCREW, TI
• Common Device Name: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19567660
• Report Number: 1220246-2024-06121
• Device Sequence Number: 14980489
• Product Code: HRS
• UDI-Device Identifier: 00888867130739
• UDI-Public: 00888867130739
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2.4 X 18MM VAL NEAR CORTEX SCREW, TI
• Device Catalogue Number: AR-8916VNC-18
• Device Lot Number: 1100274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown