MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.75MM BC KNOTLESS SWIVELOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/2/2023, it was reported by a sales representative via phone that an ar-2324kbcc biocomposite knotless swivelock green inserter started to warp and break when the anchor met the bone.The surgeon was unable to insert the anchor as it was spinning in the bone due to the shaft breaking.The broken fragments were retrieved and a new ar-2324kbcc biocomposite knotless swivelock, from a different lot number, was used to complete the case.This was discovered during an rcr procedure on (b)(6) 2023.
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: 4.75MM BC KNOTLESS SWIVELOCK
• 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: emily shafer ; 8009337001
• MDR Report Key: 17182032
• Report Number: 1220246-2023-06962
• Device Sequence Number: 20416356
• Product Code: MAI
• UDI-Device Identifier: 10888867351285
• UDI-Public: 10888867351285
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• 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): 10/22/2024

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: 08/31/2026
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 15003304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2022
• 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