MAUDE Adverse Event Report: ARTHREX, INC. HIP LABRAL SCORPION; MANUAL INSTR, GENERAL SURGICAL

Model Number	HIP LABRAL SCORPION
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
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 05/19/2025, it was reported by a sales representative via (b)(4) that an ar-16991 hip labral scorpion was being utilized for an arthroscopic hip labral repair utilizing knotless fibertak anchors.The suture fell out of the top jaw 3 times, misfired twice, and cut the repair stitch upon passing twice.The device was changed out with a new device (keeping the same needle) and were able to put in 3 subsequent anchors without issue.There is an issue with the top jaw of the scorpion causing it to limit its function.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to wear and tear incurred from repeated/extended usage in the field.Manufactured date: 15-feb-2016.

• Brand Name: HIP LABRAL SCORPION
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 22202779
• Report Number: 1220246-2025-02430
• Device Sequence Number: 6755781
• Product Code: LXH
• UDI-Device Identifier: 00888867184312
• UDI-Public: (01)00888867184312(11)160215(10)73438
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/09/2025

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: HIP LABRAL SCORPION
• Device Catalogue Number: AR-16991
• Device Lot Number: 73438
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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