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	Insufficient Information (4580)
Date of Event	12/11/2025
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, it was reported by an arthrex employee via email that for an ar-4009s, osteochondral flap repair single shot instruments, the drill bit broke within drill sleeve.This was detected during an unspecified procedure on (b)(6) 2025 when drilling for 3rd dart.Everything was kept in line.On (b)(6) 2025 - the complaint initiator replied that this was detected during an ocd fixation procedure on (b)(6) 2025 when drilling for 3rd dart.The procedure was completed successfully as the broken drill bit was removed using the wire driver and a new drill bit was opened.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 the complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically, excessive force, and/or incorrect surgical technique.The complaint allegation was confirmed based on the evaluation of the customer provided image, which showed the drill pin detached from the hub at the weld.

• 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: 23935257
• Report Number: 1220246-2025-05934
• Device Sequence Number: 9527890
• Product Code: LXH
• UDI-Device Identifier: 00888867031272
• UDI-Public: (01)00888867031272(11)251029(17)300930(10)15522286
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/13/2026

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: 15522286
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• 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