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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
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.Complaint confirmed.One unpackaged ar-1778p-cp was received for investigation.Visual inspection identified that the plastic overmold along the swivelock driver had disassociated from the metal sleeve.The section of the molded plastic that detached from the handle was not returned for analysis.The most likely cause for the reported failure can be attributed to interference between the plastic and other instrumentation during use.
Event or Problem Description
On 11/3/2021, it was reported by an arthrex employee via email that an ar-1778p-cp internalbrace implant system 4.75mm swivelock implant handle dislodge.This was discovered during a procedure on (b)(6) 2021 additional information received 11/5/2021: ar-1778p-cp swivelock handle came off the metal shaft when surgeon attempted to insert implant; however, surgeon was still able to implant swivelock peek successfully during internal brace procedure on the ankle.

• 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: 19248075
• Report Number: 1220246-2024-02812
• Device Sequence Number: 6598663
• Product Code: MAI
• UDI-Device Identifier: 00888867318120
• UDI-Public: 00888867318120
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: 10/31/2025
• Device Model Number: IB KIT, PEEK, NON-COLLAGEN COATED
• Device Catalogue Number: AR-1778P-CP
• Device Lot Number: 12044510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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