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

Model Number	DRILL SAW SPORTS 400
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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
It was reported that during a surgery, the device overheated and became very hot.It has also not been possible to disassemble the device.There was no harm for patient, operator or third party reported.No further information received.Update 05-feb-2026 - further information was received: it was reported that during the reverse total shoulder arthroplasty, the device overheated and became very hot.It has also not been possible to disassemble the device.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a different device from another manufacturer.It was not necessary to switch the surgical technique or do a second surgery.

• 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 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 24377072
• Report Number: 1220246-2026-00647
• Device Sequence Number: 5572726
• Product Code: HWE
• UDI-Device Identifier: 00888867223318
• UDI-Public: (01)00888867223318(11)210909(10)14145941
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 14145941
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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