MAUDE Adverse Event Report: ARTHREX, INC. PEEK, SWIVELOCK TT, 4.75X19.1MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	PEEK, SWIVELOCK TT, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2023
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 06/20/2023, it was reported by an arthrex employee via sems that an ar-2324 pctt peek knotless swivelock broke.This occurred during a case on (b)(6), 2023, the insertion angle was different from the path taken by the punctor, becoming weak and the anchor loosened.There was no additional information provided additional information was requested.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information was provided on 07/28/2023, it was reported that this occurred in a procedure for a ligament injury that was corrected.All of the fragments were recovered, and no remains were left in the patient, another anchor was opened, and he completed the surgery.

• Brand Name: PEEK, SWIVELOCK TT, 4.75X19.1MM
• 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: 17286708
• Report Number: 1220246-2023-07092
• Device Sequence Number: 6185674
• Product Code: MAI
• UDI-Device Identifier: 00888867098121
• UDI-Public: 00888867098121
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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: PEEK, SWIVELOCK TT, 4.75X19.1MM
• Device Catalogue Number: AR-2324PCTT
• Device Lot Number: 15014618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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