MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 3.0MM S-TAK; ORTHOPEDIC MANUAL SURG INSTR

Model Number	PERC INSERT KIT FOR 3.0MM S-TAK
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to a manufacturing issue; however, due to the device not being returned, we are unable to confirm the reported event.
Event or Problem Description
It was reported on 07/15/2022 by a facility representative via sems that an ar-1934pi-30nitinol wire would not fit through the dilator in the percutaneous kit.This was discovered during a case with no patient harm.Per facility: "during a superior capsular reconstruction, the surgeon was trying to insert some 3.0 suturetaks percutaneously on the glenoid.When doing the sequential steps to insert the anchors percutaneously with the kit, the nitinol wire would not fit through the dilator in the percutaneous kit.The sizing was very off it seems, therefore the kit was unable to be used due to it not functioning properly.We had to discard the kit and open a new one.The kit was very clearly defective".

• Brand Name: PERC INSERT KIT FOR 3.0MM S-TAK
• 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: 19387972
• Report Number: 1220246-2024-03799
• Device Sequence Number: 20566029
• Product Code: LXH
• UDI-Device Identifier: 00888867024151
• UDI-Public: 00888867024151
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: PERC INSERT KIT FOR 3.0MM S-TAK
• Device Catalogue Number: AR-1934PI-30
• Device Lot Number: 14950537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2022
• 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