MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, 4.0MM X 13CM; SAW BLADE

Model Number	EXCALIBUR, 4.0MM X 13CM
Medical Device Problem Codes	Overheating of Device (1437); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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 15th august 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-8400ex, excalibur, 4.0 mm x 13 cm, the handle was overheated, resulting in the deformation of the connection between the grinding head(ar-8400ex) and the handle.As a result, the product cannot be used normally.This was detected during an arthroscopic exploration and internal fixation of acromioclavicular joint dislocation procedure on (b)(6) 2025.The procedure was completed successfully by using another new ar-8400ex.There was no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-8400ex batch 15286955 was received for evaluation.Visual inspection revealed that the hub was melted.Due to the damage to the hub, the two tubes become stuck together.The functional test revealed that both tubes are stuck together and not moving.The most likely cause of the reported and observed failure is user use.Improper setting of the device in the handpiece may cause irreversible damage to the device.Directions for use dfu-0215-eo revision 1.Disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection, and shaverdrill devices.K.Directions for use i.Device insertion and removal for use with hand-controlled and non-hand-controlled handpieces: 1.To insert a disposable device, insert the device into the handpiece so that the plastic tab mates with the handpiece slot.The tab should be pushed in proximally as far as possible for a positive lock.Directions for use dfu-0154-eor6_fmt_en ar revision 6.Synergy and adapteur power system ii (aps ii) shaver handpieces 8.To avoid damaging the shaver handpiece and disposables used with the shaver handpiece, do not subject the disposable to excessive force.Excessive force may render the disposable and/or shaver handpiece inoperable.Directions for use dfu-0215-eo revision 1.Disposable arthroscopic shaver blades, burrs, powerpick, powerasp, nanoresection, and shaverdrill devices.F.Precautions 9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).10.Running the device without the flow of irrigation (dry) will cause the device to excessively heat and may cause a thermal burn.

• Brand Name: EXCALIBUR, 4.0MM X 13CM
• Common Device Name: SAW BLADE
• 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: 22945546
• Report Number: 1220246-2025-03710
• Device Sequence Number: 9865259
• Product Code: GFA
• UDI-Device Identifier: 00888867043589
• UDI-Public: (01)00888867043589(11)240712(17)290630(10)15286955
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/05/2025

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: EXCALIBUR, 4.0MM X 13CM
• Device Catalogue Number: AR-8400EX
• Device Lot Number: 15286955
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown