MAUDE Adverse Event Report: ARTHREX, INC. 2.4MM BIO-SUTURETAK DISPOSABLES KIT; MANUAL INSTR, GENERAL SURGICAL

Model Number	2.4MM BIO-SUTURETAK DISPOSABLES KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023 by an arthrex employee via sems that an ar-1934-24ds drill bit got stuck in the ar-1934bcf-24-2 drill sleeve.It was used at the elbow head.Used a new product, and the case was completed.Case involvement, no patient effect.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 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 device was not returned for investigation and no photos were provided.Based on the provided information the drill bit got stuck in the drill sleeve, the most likely cause is user error.Due to the application of prying or leveraging forces onto the drill bit while in the drill sleeve.Complaint is not confirmed.

• Brand Name: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19359468
• Report Number: 1220246-2024-03585
• Device Sequence Number: 12354331
• Product Code: MDM
• UDI-Device Identifier: 00888867023864
• UDI-Public: 00888867023864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: 2.4MM BIO-SUTURETAK DISPOSABLES KIT
• Device Catalogue Number: AR-1934-24DS
• Device Lot Number: 14475982
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown