MAUDE Adverse Event Report: ARTHREX, INC. DRILL SAW SPORTS 400; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL SAW SPORTS 400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 08-jan-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-400 drillsaw sports 400 system handpiece broke internally.It was reported that when removing the graft using the saw, the motor malfunctioned, causing the sports 400 handpiece to break internally.This was discovered during an hth technique knee arthroscopy procedure with no patient harm.Additional information provided 13-jan-2026: it was further reported that this was discovered after use, upon finishing the surgery and removing the saw blade, the breakage of the pins on the ar-400 handpiece was observed and therefore it is not known when the breakage occurred.The blade did not break within the patient and no fragments were produced.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 findings: dark brown debris found throughout drill seals and bearings affected.Physical damage found on rear cover scratches/dents.Electronic cover shows signs of impact.Corrective measures: drill needs complete cleaning.Affected parts need to be replaced, load and final testing.

• Brand Name: DRILL SAW SPORTS 400
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24117667
• Report Number: 1220246-2026-00253
• Device Sequence Number: 12274549
• Product Code: HWE
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• 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): 05/18/2026

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: DRILL SAW SPORTS 400
• Device Catalogue Number: AR-400
• Device Lot Number: 15015989
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown