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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopic subtalar artrodesis surgery the shaver produced metal chips.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
Update avoe 02-oct-2024: it was confirmed that the fragments remained inside the patient as these were too small to retrieve.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-8550bc bone cutter was received for investigation.Upon visual inspection, it was noted that the returned device had nicks around the edges of the outer tube windows.After removing the outer tube, the inner tube was inspected, and it was noted that there were scratches and marks on the tip of the inner tube.It was further noted that the cutting edge of the inner tube was damaged and nicked.Striations were also noted within the outer tube's inner surface.The most likely cause for the reported failure can be attributed to user error.

• 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: 20359055
• Report Number: 1220246-2024-07975
• Device Sequence Number: 20864703
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: (01)00888867043930(11)231206(17)281130(10)15176612
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 01/30/2025

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: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 15176612
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 10/02/2024; 01/06/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/15/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2023
• 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