MAUDE Adverse Event Report: ARTHREX, INC. 300 SAGITTAL SAW BLADE 25X5.5X0.6

Model Number	300 SAGITTAL SAW BLADE 25X5.5X0.6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy the device broke.Per complaint reporter there was no harm for patient, operator or third party.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 04-dec-2024 it was confirmed that no part of the device broke.The device didn`t work during surgery.Update avoe 17-dec-2024 since the description "didn`t work" is not really applicable for a saw blade, which is affected in this case, further questions were asked.Further information was provided that the device indeed broke.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-300-044s sagittal saw blade for arthrex 300, 25 x 5.5 x 0.6 mm serial/batch number (b)(6) was received for evaluation.Visual inspection revealed that the blade was broken into two pieces.The evaluation of the pieces shows a bend right at the breakage, most likely as a consequence of excessive pressure during use.Functional testing was performed due to the damage to the device.The most likely cause of the reported failure is user error, specifically excessive pressure during use.Directions for use (dfu) saw blades for arthrex 600 and arthrex 300 power systems, section k.Contact pressure.Excessive contact pressure has to be avoided because this might lead to damage to the blade surfaces.Chipping of the blades.Reduced service life of saw blades.

• Brand Name: 300 SAGITTAL SAW BLADE 25X5.5X0.6
• 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: 21025715
• Report Number: 1220246-2024-09065
• Device Sequence Number: 8310652
• Product Code: HWE
• UDI-Device Identifier: 00888867028289
• UDI-Public: (01)00888867028289(11)210814(17)260630(10)030422
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 03/10/2025

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 Expiration Date: 06/30/2026
• Device Model Number: 300 SAGITTAL SAW BLADE 25X5.5X0.6
• Device Catalogue Number: AR-300-044S
• Device Lot Number: 030422
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2021
• 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