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

Model Number	LABRAL SCORPION QL WITH FLUSHPORT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that durng a labral repair surgery the mounth of the labral scorpion did not fully close, causing the device to misfire and not function as intended.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.-visual evaluation of the device noted that the jaw of the labral scorpion ql with flushport does not close completely as intended.This is a known internal manufacturing issue addressed by ncr-28217.

• Brand Name: LABRAL SCORPION QL WITH FLUSHPORT
• 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: 22004156
• Report Number: 1220246-2025-02001
• Device Sequence Number: 7135597
• Product Code: LXH
• UDI-Device Identifier: 00888867293403
• UDI-Public: (01)00888867293403(11)240523(10)15253237
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/11/2025

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 WITH FLUSHPORT
• Device Catalogue Number: AR-13998QLF
• Device Lot Number: 15253237
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown