MAUDE Adverse Event Report: ARTHREX, INC.; ORTHOPEDIC MANUAL SURG INSTR

Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 15-jan-2026, it was reported by a facility representative via (b)(4) that an ar-13991n scorpion needle tip fell off and into the patient and the piece that fell into the patient remains inside the patient.This was discovered during an unspecified procedure.Additional information has been requested.Additional information provided 27-jan-2026: it was further reported that this occurred during a left shoulder arthroscopy, left rotator cuff repair procedure with a 15-minute delay and an additional 15mm of anesthesia administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: UNK
• 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: 24270012
• Report Number: 1220246-2026-00435
• Device Sequence Number: 10714620
• Product Code: LXH
• UDI-Device Identifier: 00888867015920
• UDI-Public: (01)00888867015920(11)250422(17)300331(10)15424111
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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