MAUDE Adverse Event Report: ARTHREX, INC. BC SWIVELOCK, 3.9X17.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BC SWIVELOCK, 3.9X17.9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/12/2024, a sales representative via sems-(b)(4) reported that an ar-2326bcc suture anchor, biocomposite swivelock anchor broke during use (see photo).A suture (1.5mm labraltape) was placed through the tendon and loaded into the eyelet of the anchor.A pilot hole was drilled in the calc to accommodate a 3.9mm swivelock.As they slid the anchor down to the incision to implant into the bone, the side of the eyelet broke and was no longer functional.The patient was not injured and the case was completed without issues by opening an additional anchor.The anchor and eyelet were obtained from the case.This was discovered during an achilles tendon repair procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 9/18/2024: all fragments were retrieved.The case was delayed less than 1 minute with no additional anesthesia administered.A 3.4mm drill was used to prepare a pilot hole.However, the anchor never made contact with the patient.The eyelet broke before they ever inserted the anchor into bone.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection identified that the eyelet of the suture anchor, biocomposite swivelock®, 3.9 x 17.9 mm, ve5, had broken off, per the customer-provided photo.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: BC SWIVELOCK, 3.9X17.9MM
• 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: jared engle ; 8009337001
• MDR Report Key: 20290033
• Report Number: 1220246-2024-07813
• Device Sequence Number: 7209119
• Product Code: MAI
• UDI-Device Identifier: 00888867311282
• UDI-Public: (01)00888867311282(11)240228(17)280131(10)15213212
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K230435
• 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): 03/07/2025

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: BC SWIVELOCK, 3.9X17.9MM
• Device Catalogue Number: AR-2326BCC
• Device Lot Number: 15213212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2024
• 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