MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 2.9MM P-LCK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PERC INSERT KIT FOR 2.9MM P-LCK
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 01/18/2024, it was reported by a sales representative via (b)(4) that an ar-1923pk percutaneous insertion kit had a crimp that caused an issue with insertion.This occurred during a case.No additional information was provided, and additional information has been asked.
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.
Additional Manufacturer Narrative
Additional information: b3, b5, g3.
Event or Problem Description
Additional information was provided on 2/1/2024 where the sales representative stated this occurred on (b)(6) 2023 during a labral repair case.Another 2.9 pushlock percutaneous insertion kit was opened to complete the repair.
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 descriptions, and any additional information from the field, arthrex concluded that an internal manufacturing issue is the most likely cause of the reported failure.The complaint allegation was confirmed based on the customer's attached picture, which displays a shaft's tip with a deformity on the inside diameter.

• Brand Name: PERC INSERT KIT FOR 2.9MM P-LCK
• 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: 18669794
• Report Number: 1220246-2024-00855
• Device Sequence Number: 7316724
• Product Code: LXH
• UDI-Device Identifier: 00888867096745
• UDI-Public: 00888867096745
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 05/12/2025

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: PERC INSERT KIT FOR 2.9MM P-LCK
• Device Catalogue Number: AR-1923PK
• Device Lot Number: 15157668
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 02/01/2024; 04/23/2025
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 12/16/2024; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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