MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP; BONE FIXATION PLATE

Model Number	KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/25/2022, it was reported by a sales representative via phone that an ar-2658tr knotless distal clavicle plate button tightrope did not seat properly and pulled out.Surgeon used a dog bone to complete the case.This was discovered during a clavicle fracture with ac joint procedure on (b)(6) 2022.Case was completed successfully without further issues.
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 user error due to misaligned insertion and/or improper bone preparation.

• Brand Name: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Common Device Name: BONE FIXATION PLATE
• 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: 19154195
• Report Number: 1220246-2024-02210
• Device Sequence Number: 7921061
• Product Code: HRS
• UDI-Device Identifier: 00888867271814
• UDI-Public: 00888867271814
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: 12/31/2025
• Device Model Number: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Device Catalogue Number: AR-2658TR
• Device Lot Number: 12439105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown