MAUDE Adverse Event Report: ARTHREX, INC. PROSTOP SUBTALAR ARTHROEREISIS IMPLANT; BONE FIXATION SCREW/PLATE

Model Number	PROSTOP SUBTALAR ARTHROEREISIS IMPLANT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2nd may 2025, it was reported by an arthrex employee via email that an ar-4211-16, prostop¿ subtalar arthroereisis implant, 11 x 16 mm, was expired.On 4th april 2025, an arthrex employee received an email from the level 2 nurse at the hospital ordering a gear for a case on (b)(6) 2025.It was for a calc osteotomy with tendon transfer procedure.The appropriate gear was sent in that was requested for the pathology booked.Whilst discussing the case with the surgeon, they were told that it was an arthroereisis screw and not an arthrodesis screw, which was booked.The patient was on the table at this stage and under anesthesia.The arthrex employee clarified that the correct screw was sent based on the original booking made by the hospital.However, the surgeon wanted to do a different procedure which required a different screw which was not sent in and they were only made aware when the patient was in the operating room.Another hosoital was called ahead and was asked to organize, triple bag, the instrument tray and the implants for the prostop screw.The gear was dropped off downstairs.The loan screw was handed onto the sterile field from one of the nursing staff.While the surgeon was closing up, the representative checked the implant box and saw that the implanted screw had expired, (b)(6) 2024, the screw was sterile.The surgeon was made aware and decided to remove it and exchange it for an appropriate screw that was in date.This was detected during use in a flat foot procedure on (b)(6) 2025.The procedure was completed successfully as the surgeon decided to remove the expired screw and exchange it for an appropriate screw that was in date.8th may 2025 - the arthrex employee replied that it was detected during use in a flat foot correction procedure on (b)(6) 2025.The "loan screw" mentioned above was the screw that was purchased by another hospital.A guidewire was placed into the screw and a cannulated screwdriver was placed over the wire and used to take out the expired screw.The screw that was in date was packaged with a bundle of screws sent from the (b)(6).It was the arthrex rep that called.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to misuse due to abnormal use, as the device was used after the listed expiration date.Refer to dfu-1037-eo section k, which states, "sterile devices must be stored in the original unopened packaging, away from moisture and should not be used after the expiration date.

• Brand Name: PROSTOP SUBTALAR ARTHROEREISIS IMPLANT
• Common Device Name: BONE FIXATION SCREW/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: 21996196
• Report Number: 1220246-2025-01970
• Device Sequence Number: 8480023
• Product Code: HWC
• UDI-Device Identifier: 00888867033511
• UDI-Public: (01)00888867033511(11)200109(17)241231(10)10558151
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 Expiration Date: 12/31/2024
• Device Model Number: PROSTOP SUBTALAR ARTHROEREISIS IMPLANT
• Device Catalogue Number: AR-4211-16
• Device Lot Number: 10558151
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown