MAUDE Adverse Event Report: ARTHREX, INC. FASTPASS SCORPION SL-MF WITH FLUSHPORT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FASTPASS SCORPION SL-MF WITH FLUSHPORT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a shoulder surgery the surgeon felt a click as the needle passed through the cuff.When the forceps came out, it was no longer possible to close them completely.The initial action of grasping the tendon was therefore no longer possible.When the second device was used, the scenario was repeated.No part of the devices broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-13999mff fastpass scorpion sl-mf with flushport lot number: 15208920 was received for investigation.Visual inspection noted that when the device was actuated, the jaws would not close completely.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle.

• Brand Name: FASTPASS SCORPION SL-MF WITH FLUSHPORT
• 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: 19549024
• Report Number: 1220246-2024-05885
• Device Sequence Number: 14665493
• Product Code: LXH
• UDI-Device Identifier: 00888867293410
• UDI-Public: 00888867293410
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/23/2024

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 SL-MF WITH FLUSHPORT
• Device Catalogue Number: AR-13999MFF
• Device Lot Number: 15208920
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2024
• 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