MAUDE Adverse Event Report: ARTHREX, INC. BONE CUTTER,5.5MM X 13CM; SAW BLADE

Model Number	BONE CUTTER,5.5MM X 13CM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the knee arthroscopy, the device caused metal abrasion and turned black at the tip.The metal abrasion was retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence showing an ar-8550bc bone cutter, batch 15477758, exhibiting surface damage.Based on the information available ¿ including photographic evidence, event description, and any additional field input ¿ arthrex has determined the most likely cause of the reported issue.The most likely cause is attributed to use-related factors, specifically excessive side-loading during use.This determination is consistent with the precautions described in dfu-0215-eo, revision 1 ¿ disposable arthroscopic shaver blades, burrs, powerpick¿, powerasp¿, nanoresection¿, and shaverdrill¿ devices, which state: f.Precautions: (6).Do not allow the rotating portion of any device to contact metallic objects (e.G., cannulas, arthroscopes).Such contact may cause damage ranging from edge dulling to fracture of the tip.If contact occurs, inspect the device and replace it if cracks, fractures, or dulling are observed.(7).Excessive side-loading during use does not improve cutting performance and may cause irreversible damage to the device.(8).Excessive loading on the powerasp device may disengage the cam mechanism and stall cutting effectiveness.

• Brand Name: BONE CUTTER,5.5MM 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: 24518974
• Report Number: 1220246-2026-01235
• Device Sequence Number: 15883923
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: (01)00888867043930(11)250805(17)300731(10)15477758
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 03/05/2026

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: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 15477758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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