MAUDE Adverse Event Report: Arthrex, Inc. LOW PROFILE LOCKING SCREW 3.5 MM X 26 MM; BONE FIXATION SCREW/PLATE

Model Number	LOW PROFILE LOCKING SCREW 3.5 MM X 26 MM
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 28th august 2026, it was reported by an arthrex employee via email that for an ar-8935l-26s, low profile locking screw, titanium, 3.5 x 26 mm, sterile, im, it failed to lock with the plate.This was detected during use in an unknown procedure on (b)(6) 2026.The procedure was completed successfully after confirming the attachment of the locking drill sleeve, a new screw of the same length was used to achieve locking.No significant surgery delay reported.No additional anesthesia administered to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: LOW PROFILE LOCKING SCREW 3.5 MM X 26 MM
• Common Device Name: BONE FIXATION SCREW/PLATE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50731817
• Report Number: 1220246-2026-04677
• Device Sequence Number: 16098767
• Product Code: HWC
• UDI-Device Identifier: 00888867050983
• UDI-Public: (01)00888867050983(11)241111(17)291031(10)15345389
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143614
• 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
• Report Date (Section B): 09/11/2026

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: LOW PROFILE LOCKING SCREW 3.5 MM X 26 MM
• Device Catalogue Number: AR-8935L-26S
• Device Lot Number: 15345389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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