MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE OSTEOTOME SHORT 12 MM; MANUAL INSTR, GENERAL SURGICAL

Model Number	LOW PROFILE OSTEOTOME SHORT 12 MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
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 03-feb-2026, it was reported by a sales representative via (b)(4) that an ar-13203-12 osteotome was damaged during use.Discovered during reprocessing with no patient effect.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 complaint allegation is confirmed by the attached picture, which shows one of the ends of the device was bent/damaged.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to wear and tear damage resulting from repeated prying/leveraging, and extended use of the device in the field.

• Brand Name: LOW PROFILE OSTEOTOME SHORT 12 MM
• 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 -194
• Manufacturer Contact: jared engle ; 8009337001-73216
• MDR Report Key: 24387447
• Report Number: 1220246-2026-00665
• Device Sequence Number: 10185480
• Product Code: MDM
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/08/2026

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: LOW PROFILE OSTEOTOME SHORT 12 MM
• Device Catalogue Number: AR-13203-12
• Device Lot Number: 1068642217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2022
• 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