MAUDE Adverse Event Report: ARTHREX, INC. FASTPASS SCORPION-MULTIFIRE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	FASTPASS SCORPION-MULTIFIRE
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/21/2022, it was reported by an arthrex employee via sems that an ar-13997mf multifire fastpass scorpion head broke.This was discovered during an rcr procedure on (b)(6) 2022.Surgeon used a suture lasso to complete the case.
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 confirmed.Upon visual inspection, it was noted that the upper jaw of the device had broken at the trapdoor.The trap door and broken piece of the upper jaw were not returned for investigation.The cause of this remains undetermined however, probable cause can be attributed to the application of prying/leveraging forces.

• Brand Name: FASTPASS SCORPION-MULTIFIRE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14915117
• Report Number: 1220246-2022-05181
• Device Sequence Number: 2033272
• Product Code: LXH
• UDI-Device Identifier: 00888867015975
• UDI-Public: 00888867015975
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/13/2022

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-MULTIFIRE
• Device Catalogue Number: AR-13997MF
• Device Lot Number: 10235413
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown