MAUDE Adverse Event Report: ARTHREX, INC. FASTPASS SCORPION; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	FASTPASS SCORPION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/08/2023, it was reported by a distributor via sems that an ar-13997sf fastpass scorpion broke.This occurred during a case on (b)(6) 2023 when the point of the scorpion broke off.No additional information was provided.Additional information has been requested.
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
Complaint is confirmed.Upon visual evaluation revealed that the jaw is broken off.This is typically caused by applying excessive force while grasping and manipulating tissue or when applying excessive leveraging forces.The cause remains undetermined.Functional test was not performed due to the damage to the device.

• Brand Name: FASTPASS SCORPION
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16618550
• Report Number: 1220246-2023-06498
• Device Sequence Number: 5996464
• Product Code: LXH
• UDI-Device Identifier: 00888867015982
• UDI-Public: 00888867015982
• Combination Product (Y/N): N
• Initial Reporter Country: DR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 12685435
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown