MAUDE Adverse Event Report: ARTHREX, INC. LOCKING THIRD TUBULAR PLATE, TI, 6H; BONE FIXATION PLATE

Model Number	LOCKING THIRD TUBULAR PLATE, TI, 6H
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/19/2024, it was reported by a sales representative via sems-(b)(4) that an ar-8935l-10 low profile locking screw went straight through the ar-9943t-06 locking third tubular plate.This occurred during a procedure, the 3.5 locking screw went straight through the plate with little to no pressure like he wasn¿t cranking on the screw it just went straight through the plate, which isn¿t normal.They took everything out and replaced it with another ar-9943t-06 in the tray which had no issues and used a new ar-8935l-10 screw with no issues.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, the five threaded holes were stripped/damaged, and the oblong hole was chipped.Functional testing was not performed with the screw returned and did not lock as required due to the damage of the holes.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion or/and misaligned insertion of the screw.Per dfu-0192-eo rev 6 g precautions 4.Repeated bending of the plate at the same location, or by creating excessive acute angles may potentially lead to premature plate fatigue, failure and or breakage in situ.5.Screws should be inserted by hand and not with powered equipment.

• Brand Name: LOCKING THIRD TUBULAR PLATE, TI, 6H
• 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: 19927320
• Report Number: 1220246-2024-07061
• Device Sequence Number: 15547348
• Product Code: HRS
• UDI-Device Identifier: 00888867256163
• UDI-Public: 00888867256163
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111253
• 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,Followup
• Report Date (Section B): 09/30/2024

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 THIRD TUBULAR PLATE, TI, 6H
• Device Catalogue Number: AR-9943T-06
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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