MAUDE Adverse Event Report: ARTHREX, INC. OSTEOCON FLAP REPR SINGSHOT INST; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OSTEOCON FLAP REPR SINGSHOT INST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 (b)(6) 2025, a distributor reported via (b)(4) that (qty.2) ar-4009s single-shot instruments were requested to be removed from consignment during an ehile orif of ocd.No patient was affected.On 15-dec-2025 additional information was received.The rep advised that the drill broke twice while doing an ocd repair.They had to open a second single-shot disposable, but the drill broke again so they opened a multi-shot guide.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The complaint allegation cannot be confirmed.The most likely cause is attributed to user-related factors, such as the application of excessive force or off-axis insertion during use.

• Brand Name: OSTEOCON FLAP REPR SINGSHOT INST
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 23895759
• Report Number: 1220246-2025-05820
• Device Sequence Number: 4605711
• Product Code: LXH
• UDI-Device Identifier: 00888867031272
• UDI-Public: (01)00888867031272(11)250820(17)300731(10)15485830
• 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): 04/10/2026

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: OSTEOCON FLAP REPR SINGSHOT INST
• Device Catalogue Number: AR-4009S
• Device Lot Number: 15485830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• 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