MAUDE Adverse Event Report: ARTHREX, INC. Y-PLATE, 1.4MM, 6 HOLE; BONE FIXATION PLATE

Model Number	Y-PLATE, 1.4MM, 6 HOLE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2022
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to over-torqueing the screw when inserting into the plate.
Event or Problem Description
On 12/9/2022, it was reported by a sales representative via sems that the locking screws could not be implanted in an ar-18714p-10 plate and an ar-18714p-18 plate.The screws kept seating proud on the plates and spinning.This was discovered during a procedure.Additional information received on 12/13/2022: this was discovered during a 5th metacarpal fracture procedure on (b)(6) 2022.Multiple screws, such as: ar-18714v-06 1.4x6mm locking screw and ar-18714v-07 1.4x7mm locking screw, were attempted to be use, but still could not be implanted through the plates.Neither the plates nor the screws were used in the procedure as it was completed pinning the proximal phalanx with k-wires.

• Brand Name: Y-PLATE, 1.4MM, 6 HOLE
• 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: 19463950
• Report Number: 1220246-2024-04868
• Device Sequence Number: 12425273
• Product Code: HRS
• UDI-Device Identifier: 00888867315563
• UDI-Public: 00888867315563
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: Y-PLATE, 1.4MM, 6 HOLE
• Device Catalogue Number: AR-18714P-10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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