MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP BC KL 5.5MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SWIVELOCK, SP BC KL 5.5MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/25/2024, it was reported by a sales representative via email that an ar-2323kbcsp knotless biocomposite self-punching swivelock eyelet dislodged when it was malleted in for insertion.Prior to the insertion of the swivelock, the surgeon prepared the bone socket with an instrument from another manufacturer.The surgeon opted to insert the anchor without a punch as the patient had very strong bones.Upon malleting the anchor, the eyelet dislodged.The surgeon reloaded the eyelet, held the sutures tight to the inserter with a hemostat, and attempted to insert the anchor again, but it was unsuccessful.The surgeon opened a second ar-2323kbcsp knotless biocomposite self-punching swivelock.The eyelet on the second anchor also popped off.The broken fragments from both swivelocks were successfully removed from the patient.An implant from another manufacturer was attempted to be used, but it was also unsuccessful.The surgeon then determined that the bone was very hard and prepared a punch hole using a 4.5mm arthrex punch/awl.After this process, a 4.75mm knotless swivelock was bent.After adjusting the angle, the surgeon completed the repair using two 4.75mm swivelocks.This was discovered during an rcr procedure on (b)(6) 2024.
Event or Problem Description
Additional information received on 11/4/2024: the 4.75mm swivelock that bent was part number ar-2324kbcc.Everything from each failed device was removed from the patient, and a new ar-2324bcc biocomposite swivelock c was used to complete the procedure.The case was delayed by five minutes with additional anesthesia to cover that length of time.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Visual evaluation of the customer-provided pictures noted an ar-2323kbcsp knotless biocomposite self-punching swivelock eyelet shaft is bent.Refer to attachments.The complaint allegation is confirmed based on the customer-provided pictures.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SWIVELOCK, SP BC KL 5.5MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 20633546
• Report Number: 1220246-2024-08461
• Device Sequence Number: 15329985
• Product Code: MAI
• UDI-Device Identifier: 00888867384453
• UDI-Public: (01)00888867384453(11)240815(17)280731(10)15302864
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• 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,Followup
• Report Date (Section B): 09/15/2025

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: SWIVELOCK, SP BC KL 5.5MM
• Device Catalogue Number: AR-2323KBCSP
• Device Lot Number: 15302864
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: Not provided; 09/04/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/27/2024; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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