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

Model Number	FASTPASS SCORPION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/5/2023, it was reported by an arthrex subsidiary employee via sems-06050515 that an ar-13997sf fastpass scorpion had an issue.On (b)(6) 2023, a rotator cuff procedure was performed using the scorpion fastpass shoulder clamp ar-13997sf with the needle ar-13991n, 3 suture passes were made in the joint and it worked well.In the 4th suture pass the click was made, this was heard louder.When the clamp was removed from the joint, it was activated to close it but it was evidenced that it no longer made that movement.This occurred during use with no patient harm.Additional information has been requested.On 10/13/2023, the arthrex subsidiary employee provided the following information via email: no part of the scorpion or the scorpion needle broke inside the patient.The scorpion needle was discarded.No additional scorpion needle had to be used.The procedure was completed successfully.There was no adverse effect to the patient and no case delay.
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 not confirmed.One unpackaged, ar-13997sff, fastpass scorpion, batch 14971243, was received for investigation.Visual evaluation noted normal signs of wear.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 was able to properly capture the suture and fire as intended.

• 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: 18002324
• Report Number: 1220246-2023-08358
• Device Sequence Number: 7604042
• 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: 09/28/2023
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 10/25/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown