MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 4.75MM BC SWVLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 11/29/2023, it was reported by a sales representative via email that an ar-2324bct-2 biocomposite swivelock eyelet broke upon insertion.This was discovered during a procedure on (b)(6) 2023.The case was completed using another ar-2324bct-2 biocomposite swivelock from a different lot number.Additional information received on 12/1/2023: this was discovered during an atfl and cfl internalbrace procedure.All the broken fragments were removed from inside the patient.The case was not delayed, and no additional anesthesia was needed.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• 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: emily shafer ; 8009337001
• MDR Report Key: 18394759
• Report Number: 1220246-2023-09621
• Device Sequence Number: 18320490
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: 00888867251236
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 10/29/2024

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: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2
• Device Lot Number: 15041184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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