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

Model Number	LABRAL SCORPION QL
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 09/05/2024, it was reported by a sales representative via sems-06655352 that an ar-13998ql labral scorpion jaws do not close all the way.This occurred during a case.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-13998ql labral scorpion lot number: 15256881 was received for investigation.Visual evaluation noted no problems with the exterior of the device.Functional testing was performed by using the finger of the returned device to actuate the jaws of the device.It was noted that the jaws would not close all the way.The cause can be attributed to an internal manufacturing issue addressed in ncr-28217.Refer to record cross reference.

• Brand Name: LABRAL SCORPION QL
• 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: 20278643
• Report Number: 1220246-2024-07801
• Device Sequence Number: 7563830
• Product Code: LXH
• UDI-Device Identifier: 00888867261068
• UDI-Public: 00888867261068
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/20/2025

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: LABRAL SCORPION QL
• Device Catalogue Number: AR-13998QL
• Device Lot Number: 15256881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 01/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2024
• 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