MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,3.5 MINI,30MM LGTH; BONE FIXATION SCREW/PLATE

Model Number	COMPR FT SCRW,3.5 MINI,30MM LGTH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via e-mail that a patient underwent a first mtp joint fusion on (b)(6) 2021 and on the patients normal follow-up this week, an x-ray shows that both screws have broken and the joint has not fused.Attached are the x-rays from the post-op visit.No additional information.Additional information requested.Additional information provided 09/29/2021: the date of the primary procedure was on (b)(6) 2021 for a first mtp fusion.The primary procedure took place at (b)(6) surgicenter, arthrex account (b)(4).The implanted device(s) were ar-8730-32h and ar-8730-30h.If the patient agrees to a second surgery, then the broken screws would be removed.The patient is currently seeking a second opinion.No revision scheduled as this time.
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.Complaint confirmed.Visual evaluation identified that both screws had fractured.However, without the return of the device, further investigation cannot be performed.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: COMPR FT SCRW,3.5 MINI,30MM LGTH
• 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: 19490025
• Report Number: 1220246-2024-05159
• Device Sequence Number: 7107024
• Product Code: HRS
• UDI-Device Identifier: 00888867127043
• UDI-Public: 00888867127043
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K201132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/07/2024

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: COMPR FT SCRW,3.5 MINI,30MM LGTH
• Device Catalogue Number: AR-8730-30H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 06/07/2024
• 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