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	Foreign Body In Patient (2687)
Date of Event	01/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ankle arthroscopy the shaver device bone cutter ar-8550 (lot: 15031463) was dropping ¿scobs¿.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.Update avoe (b)(6) 2024 it was confirmed that metall shavings were produced with the device and not all fragments could be removed from the patient.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.The complaint allegation is confirmed.One unpackaged ar-8550bc bone cutter, 5.5 mm x 13 cm serial/batch number (b)(6), was received for evaluation.Functional testing was not performed due to damage to the device.After removing the outer tube, horizontal wear was observed at the proximal end at the tip and along the inner tube tip.The inner and outer tube¿s cutting edges have nicks.The evidence shows that the event is consistent with prying/leveraging against bone.Black and brown marks were also noted inside the outer tube and around the tip of the inner tube, most likely due to running the device without irrigation.The observed condition is likely due to excessive ¿side-loading¿ on the device during use.According to dfu-0215-7 at revision 0.F.Precautions.7.Excessive ¿side-loading¿ on the device during use does not improve cutting performance and in extreme cases will cause irreversible damage to the device.9.9.Irreversible damage to all devices will result if they are run without the flow of irrigation (dry).

• 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: emily shafer ; 8009337001
• MDR Report Key: 18544607
• Report Number: 1220246-2024-00401
• Device Sequence Number: 7922980
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: 15031463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2022
• 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