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

Model Number	LABRAL SCORPION
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Labral scorpion hand instrument was etched with multifire scorpion sl on top of the handle.Related etching does not pertain to a labral scorpion hand instrument and was etched incorrectly.Please see agile print ar-13998.For correct etching and specification.Please refer to capa-00278.
Event or Problem Description
It was reported that the ar-13998 was received having ¿fastpass scorpion sl¿ etched on the top of the handle instead of ¿labral scorpion¿ as previously seen on older devices.

• Brand Name: LABRAL SCORPION
• 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: 19079196
• Report Number: 1220246-2024-01942
• Device Sequence Number: 6752899
• Product Code: LXH
• UDI-Device Identifier: 00888867015999
• UDI-Public: 00888867015999
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/10/2024

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: LABRAL SCORPION
• Device Catalogue Number: AR-13998
• Device Lot Number: 11818720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown