MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, PEEK, NON-COLLAGEN COATED; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IB KIT, PEEK, NON-COLLAGEN COATED
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant labels are missing.The problem was noticed after the surgery/ treatment.There was no harm or adverse event for patient, operator or third party reported.No further information received.
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.Complaint confirmed.A trend was identified for this reported event for the ar-1778p-cp batch 11360087 and, as a result, a part was pulled from inventory.The implant system was opened and no patient labels were present in the packaging.Per the bom and lcn0046068 for part ar-1778p-cp batch 11360087 there are to be patient labels present in the packaging.Ncr-16438 was initiated to address the nonconformance.

• Brand Name: IB KIT, PEEK, NON-COLLAGEN COATED
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 19186119
• Report Number: 1220246-2024-02419
• Device Sequence Number: 7403244
• Product Code: MAI
• UDI-Device Identifier: 00888867318120
• UDI-Public: 00888867318120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101823
• 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): 04/25/2024

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 Expiration Date: 06/30/2025
• Device Model Number: IB KIT, PEEK, NON-COLLAGEN COATED
• Device Catalogue Number: AR-1778P-CP
• Device Lot Number: 11360087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/25/2024
• Date Device Manufactured: 07/24/2020
• 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