MAUDE Adverse Event Report: ARTHREX, INC. IB KIT, BC, W/ CC FT AND JUMPSTART; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	IB KIT, BC, W/ CC FT AND JUMPSTART
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
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 misuse/mishandling due to damage to the device.
Event or Problem Description
On 3/30/2023, it was reported by a sales representative via email that the knob of a biocomposite swivelock from an ar-1788j-cp internalbrace, ligament augmentation repair, biocomposite, with jumpstart dressing implant system, would not turn, which resulted in the threads on the shaft of the swivelock separating from the knob.The case was completed using another ar-1788j-cp implant system.Additional information received on 4/3/2023: this was discovered during a brostrorm repair procedure.

• Brand Name: IB KIT, BC, W/ CC FT AND JUMPSTART
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 19541548
• Report Number: 1220246-2024-05831
• Device Sequence Number: 18044060
• Product Code: MAI
• UDI-Device Identifier: 00888867318137
• UDI-Public: 00888867318137
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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
• Report Date (Section B): 06/14/2024

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: 12/31/2024
• Device Model Number: IB KIT, BC, W/ CC FT AND JUMPSTART
• Device Catalogue Number: AR-1788J-CP
• Device Lot Number: 15053683
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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