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

Model Number	SCORPION-MULTIFIRE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/2024, an fda medwatch notification was received via email.A facility representative reported that an ar-13995n-1 multifire scorpion needle fragment was discovered in the patient during a postoperative x-ray.The images showed a small piece of metal in the patient's subacromial interval.The patient underwent revision surgery to have the metal fragments removed.Once removed, the metal fragment fits perfectly when placed on the tip area of the multifire scorpion needle.This occurred during a right shoulder arthroscopy rcr and bicep tenodesis procedure in (b)(6) 2024.Additional information was received on 7/3/2025: an ar-13996 multifire scorpion that was used with the broken ar-13995n-1 multifire scorpion needle was received.
Additional Manufacturer Narrative
See the investigation memo.

• Brand Name: SCORPION-MULTIFIRE
• 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: 22620708
• Report Number: 1220246-2025-03068
• Device Sequence Number: 18686351
• Product Code: LXH
• UDI-Device Identifier: 00888867015968
• UDI-Public: (01)00888867015968(11)150313(10)67984
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SCORPION-MULTIFIRE
• Device Catalogue Number: AR-13996
• Device Lot Number: 67984
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown