MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 14MMCORT; BONE FIXATION SCREW/PLATE

Model Number	LO-PRO SCRW TM,SS 3.5X 14MMCORT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One unpackaged ar-8835-14 low profile locking screw¿ was received for investigation.Visual evaluation noted that multiple screws exhibited surface wear and damaged internal drive features, consistent with implantation and subsequent explantation.Functional testing noted some resistance during engagement, which is consistent with the post-explant condition.No problem found.The complaint allegation is not confirmed, as there is no allegation against the screws.Refer to the investigation photo.
Event or Problem Description
On (b)(6) 2025, a health care professional reported via email that a clavicle plate implanted in a patient experienced a failure.According to the report, the failure occurred approximately six months post implantation, and no trauma was noted during that period.Radiographic images of the plate failure were provided for review.Additional information was received on 24-oct-2025: the original surgery was performed on (b)(6) 2025, involving an orif of the right clavicle.There were no intraoperative complications, including no case delays, added anesthesia time, or adverse events.The specific arthrex part numbers used during the procedure were not provided.The implant failure was identified six months postoperatively, occurring at the junction between the screw holes.A revision surgery has been scheduled.No additional information regarding the event is available at this time.Additional information was received on 10/30/2025: the specific arthrex part numbers used during the initial procedure have not been provided at this time.A revision surgery is scheduled to take place in two weeks.The patient did not report any prior symptoms or experience a popping sensation at the site.However, the patient began to notice pain, swelling, and deformity after engaging in routine activities.No additional information has been made available at this time.Additional information was received on 11/12/2025 by the sales representative: the revision is scheduled for (b)(6) 2025, and both surgeries will be performed by the same surgeon at the same facility as the initial surgery on 04/16/2025.The following arthrex products that were implanted in the initial surgery include ar-2657dr distal clavicle plate, long, right, ss, two ar-2665-14h fragment screw, 2.4mmx1411, hexalobe, ar-8827-20 low profile screw, 2.7 x 20 mm, cortex, ar-8827-24 low profile screw, 2.7 x 24 mm, cortex, two ar-8827l-14 low profile locking screw, ss, 2.7 x 14 mm, ar-8827l-16 low profile locking screw, ss, 2.7 x 16 mm, two ar-8827l-18 low profile locking screw, ss, 2.7 x 18 mm, ar-8827l-20 low profile locking screw, ss, 2.7 x 20 mm, ar-8835-14 low profile screw, ss, 3.5 x 14 mm, cortical, ar-8835-16 low profile screw, ss, 3.5 x 16 mm, cortical, ar-8835l-14 low profile locking screw, ss, 3.5 x 14 mm, ar-8835l-18 low profile locking screw, ss, 3.5 x 18 mm.Additional information was received on 11/25/2026: the revision surgery was performed on (b)(6) 2025.No arthrex products were implanted during the procedure.The revision was completed successfully without any case delays or additional anesthesia.The patient¿s current health status following the revision was reported as good.No additional information was provided.Additional information was received on 10-feb-2026: the following arthrex products that were explanted in the revision surgery include ar-8835l-18 low profile locking screw, ss, 3.5 x 18 mm, ar-8835l-14 low profile locking screw, ss, 3.5 x 14 mm, ar-8835-16 low profile screw, ss, 3.5 x 16 mm, cortical, ar-8835-14 low profile screw, ss, 3.5 x 14 mm, cortical, ar-8827l-18 low profile locking screw, ss, 2.7 x 18 mm, ar-8827l-16 low profile locking screw, ss, 2.7 x 16 mm, ar-8827l-14 low profile locking screw, ss, 2.7 x 14 mm, ar-8827-20 low profile screw, 2.7 x 20 mm, cortex.

• Brand Name: LO-PRO SCRW TM,SS 3.5X 14MMCORT
• 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: 24512123
• Report Number: 1220246-2026-01213
• Device Sequence Number: 9960469
• Product Code: HWC
• UDI-Device Identifier: 00888867047280
• UDI-Public: 00888867047280
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LO-PRO SCRW TM,SS 3.5X 14MMCORT
• Device Catalogue Number: AR-8835-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Distributor Facility Aware Date: 02/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown