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
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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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: 23895698
• Report Number: 1220246-2025-05819
• Device Sequence Number: 12095113
• Product Code: LXH
• UDI-Device Identifier: 00888867031272
• UDI-Public: (01)00888867031272(11)250714(17)300630(10)15466415
• 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: 15466415
• 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: 07/14/2025
• 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