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

Model Number	FASTPASS SCORPION-MULTIFIRE
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2023
Type of Reportable Event	Serious Injury
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
On (b)(6) 2023, it was reported by a sales representative via sems, that an ar-13997mf multifire fastpass scorpion gets stuck in a fire position.The surgeon had to open the shoulder.No further information was provided.Additional information received on 4/10/2023: this was discovered during an rcr procedure on (b)(6) 2023.The needle kept sticking in the fire position.The surgeon tried multiple needles without success.The case could not be completed arthroscopically.The surgeon had to open the shoulder and use free needles.Nothing broke inside the patient.Additional information received on 4/11/2023: the sales representative is unsure if additional anesthesia was administered, but the case was prolonged, due to having to open the shoulder.

• 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: 16853576
• Report Number: 1220246-2023-06657
• Device Sequence Number: 6866020
• Product Code: LXH
• UDI-Device Identifier: 00888867015975
• UDI-Public: 00888867015975
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 47641
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 05/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown