MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 22nd april 2025, it was reported by an arthrex employee via email that an ar-2324bcct, suture anchor, biocomposite swivelock® c vented, 4.75 x 19.1 mm, with fibertape® loop (blue), anchor broke during insertion.This was detected during a reduction and fixation of posterior intercondylar spine fractures of the knee joint surgery on (b)(6) 2025.No fragments were left in the patient.The procedure was completed successfully using another new ar-2324bcct.There was no patient harm and no secondary procedure needed.Ar-2324ptb was used to prepare bone socket.
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.The complaint allegation was confirmed.One unpackaged ar-2324bcct batch 15308222 was received for evaluation.Visual inspection noted that the device eyelet had pulled out of the shaft.The eyelet remains attached to the suture but shows signs of deformation.The suture connected to the eyelet appears frayed.The anchor was not received for evaluation and is presumably missing due to transit.Based on the evaluation of the customer's attached pictures, it was concluded that the anchor had broken off.No issues were found when the inner and outer molded shafts were unscrewed.The most likely cause of the reported failure is user error, including improper bone preparation, misalignment of the insertion, and misalignment of the device during insertion.

• Brand Name: BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM
• 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: 21952198
• Report Number: 1220246-2025-01865
• Device Sequence Number: 8836319
• Product Code: MAI
• UDI-Device Identifier: 00888867026841
• UDI-Public: (01)00888867026841(11)240827(17)280731(10)15308222
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/24/2025

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: BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324BCCT
• Device Lot Number: 15308222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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