MAUDE Adverse Event Report: ARTHREX, INC. THREADED HALF PIN, Ø2.0MM X 15MM X 55MM; FIXATN NAIL/BLADE/PLATE COMBO

Model Number	THREADED HALF PIN, Ø2.0MM X 15MM X 55MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/14/2022, it was reported by a sales representative via email that (2) 1411-055 threaded half pin broke.This was discovered during an unspecified procedure on (b)(6) 2022.Additional information received on 7/14/2022: patient underwent a wrist ex-fix for a badly comminuted distal radius procedure on (b)(6) 2022.While the patient was typing, the implants broke and the surgeon was alerted immediately.Per sales representative, revision surgery has not taken place to remove the implants, however, it is believed that on of the pins will remain in the patient because it's flushed within cortices and retrieving it would cause more harm than good.The other is to be removed at the time of definitive fixation - as that broken fragment is protruding from bone and will cause soft tissue irritation.Additional information requested.
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 complaint is confirmed based on the customer provided photo, which displays the broken half pins.However, without return of the device for physical evaluation, the most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces.

• Brand Name: THREADED HALF PIN, Ø2.0MM X 15MM X 55MM
• Common Device Name: FIXATN NAIL/BLADE/PLATE COMBO
• 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: 19461931
• Report Number: 1220246-2024-04861
• Device Sequence Number: 6653074
• Product Code: JDW
• UDI-Device Identifier: 00848665022308
• UDI-Public: 00848665022308
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K232897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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: THREADED HALF PIN, Ø2.0MM X 15MM X 55MM
• Device Catalogue Number: 1411-055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• 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