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

Model Number	FASTPASS SCORPION
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/22/2023, it was reported by an arthrex subsidiary employee via sems (b)(4) that an ar-13997sf fastpass scorpion¿ clamp during the surgical intervention, when mounting the suture in it and closing the bite of the clamp it is evident that the fastpass scorpion clamp does not completely close its bite.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-13997sff fastpass scorpion with flushport lot number: 14971243 was received for investigation.Visual evaluation noted that jaws would not close completely.Functional testing was performed by inserting an ar-13991n scorpion needle batch number: 959415q into the complaint device and loading a suture to pass through a suture practice pad.Functional testing revealed that the device wasn't able to properly capture the suture and fire as intended, due to the damage of the jaw.The most likely cause for the reported failure can be attributed to wear and tear.

• Brand Name: FASTPASS SCORPION
• 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: emily shafer ; 8009337001
• MDR Report Key: 18528455
• Report Number: 1220246-2024-00374
• Device Sequence Number: 7728168
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: 00888867015982
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/27/2024

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: FASTPASS SCORPION
• Device Catalogue Number: AR-13997SF
• Device Lot Number: 14971243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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