MAUDE Adverse Event Report: ARTHREX, INC. LOCKING MEDIAL HOOK PLATE, SS, 3H; BONE FIXATION PLATE

Model Number	LOCKING MEDIAL HOOK PLATE, SS, 3H
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/9/2023, it was reported by a sales representative via email that an ar-8943h-03 locking deltoid avulsion plate distal holes were off center and appeared to be damaged.Surgeon was unable to screw the locking guide into the plate as it kept cross threading.This was discovered during a talus oats procedure on (b)(6) 2023.Additional information received on 1/9/2023: case was completed using another ar-8943h-03 locking deltoid avulsion plate.
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 a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.

• Brand Name: LOCKING MEDIAL HOOK PLATE, SS, 3H
• 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: 19485820
• Report Number: 1220246-2024-05284
• Device Sequence Number: 20840707
• Product Code: HRS
• UDI-Device Identifier: 00888867052703
• UDI-Public: 00888867052703
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: LOCKING MEDIAL HOOK PLATE, SS, 3H
• Device Catalogue Number: AR-8943H-03
• Device Lot Number: 5261610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2016
• 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