MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT,SS RT,5H; BONE FIXATION PLATE

Model Number	LOCK DISTAL FIBULA PLT,SS RT,5H
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2021
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 improper bone prep and/or misaligned insertion.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).
Event or Problem Description
On 8/30/2021, it was reported by a sales representative via phone that an ar-8943br-05 distal lock fibula plate, was not threaded properly.The surgeon was unable to insert the 2.7 distal locking screw.The plate and screws were removed.This was discovered during use in an ankle arthroscopy on (b)(6) 2021. the case was completed by using the other plate from the tray.

• Brand Name: LOCK DISTAL FIBULA PLT,SS RT,5H
• 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: 19228428
• Report Number: 1220246-2024-02694
• Device Sequence Number: 12178738
• Product Code: HRS
• UDI-Device Identifier: 00888867052567
• UDI-Public: 00888867052567
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141478
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

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: LOCK DISTAL FIBULA PLT,SS RT,5H
• Device Catalogue Number: AR-8943BR-05
• Device Lot Number: 105642025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2020
• 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