MAUDE Adverse Event Report: ARTHREX, INC. OSTEOTOME BLADE, 25MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	OSTEOTOME BLADE, 25MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2024
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 07/24/2024, it was reported by a sales representative via (b)(4) that an ar-13302-25 osteotome blade broke.This occurred during a tibial osteotomy.No additional information was provided, and additional information has been asked.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-13302-25 serial/batch number (b)(6) was received for investigation.Visual inspection noted that there was a fragment broken off at the distal end.It was not returned for evaluation.Oxidation was also visible on the exterior of the device.Functional testing was not performed due to the damage of the tip.The most likely cause is attributed to wear and tear due to repeated use of the device.

• Brand Name: OSTEOTOME BLADE, 25MM
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19950038
• Report Number: 1220246-2024-07122
• Device Sequence Number: 8923264
• Product Code: MDM
• UDI-Device Identifier: 00888867010642
• UDI-Public: 00888867010642
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2024

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: OSTEOTOME BLADE, 25MM
• Device Catalogue Number: AR-13302-25
• Device Lot Number: 02981001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown