MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP BC KL 4.75MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SWIVELOCK, SP BC KL 4.75MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2025
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 01/17/2025, it was reported by a sales representative via email that an ar-3641sp self-punching knotless 2.6 fibertak anchor pulled out.After using an ar-3650ds disposables kit for 2.6 fibertak to implant the ar-3641sp self-punching knotless 2.6 fibertak, the repair suture was passed through the upper border of the subscap with a scorpion, and the repair suture was converted.Then it was tensioned no tangles.With about 1cm of slack left in the tensioning limb, the anchor pulled out.The anchor was cut out, leaving no residual implants in the patient.At this point, the subscap was debrided and left alone.Later in the procedure, the supraspinatus was addressed using an ar-3652sp fibertak rc suture anchor.All sutures were passed and then brought over to the lateral anchor on an ar-2324kbcsp swivelock.All sutures from the repair were cut, and the initial repair was completed.While shuttling the repair suture through the knotless mechanism, the entire ar-2324kbcsp swivelock anchor and eyelet pulled out of the bone.All parts of the anchor were removed from the patient.The sutures from the medial anchor were cut out, but the anchor body was well fixed in bone and remained there.The surgeon then elected to open to complete the case and then repeated a repair using hard body 4.75 swivels on both sides of the repair and not using the eyelet suture afterwards.This was discovered during an rcr procedure on (b)(6) 2025.Additional information received on 1/28/2025: the sales representative confirmed the surgeon created a larger incision to complete the repair.The case was delayed about twenty minutes with additional anesthesia.
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 cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces during use, improper bone preparation and/or prying/leveraging during use.

• Brand Name: SWIVELOCK, SP BC KL 4.75MM
• 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: 21344661
• Report Number: 1220246-2025-00335
• Device Sequence Number: 9078837
• Product Code: MAI
• UDI-Device Identifier: 00888867384538
• UDI-Public: (01)00888867384538(11)241216(17)281130(10)15362506
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SWIVELOCK, SP BC KL 4.75MM
• Device Catalogue Number: AR-2324KBCSP
• Device Lot Number: 15362506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown