MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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 (b)(6)2025, a sales representative reported via phone that qty.2 of an ar-1938bch suture anchor, biocomposite, knotless hip suturetak, and an ar-2923bch suture anchor biocomposite hip pushlock had an issue during a hip arthroscopic labral repair procedure on (b)(6) 2025.When using the first ar-1938bch suture anchor, upon shuttling the first repair stitch through, the lead stitch broke.All stitches were cut out and removed, but the anchor remained inside the patient.When using the second ar-1938bch suture anchor, upon shuttling the lead stitch, the top one-third of the anchor broke off inside the patient.The surgeon removed all stitches and the broken top of the anchor, but the remaining two-thirds of the anchor stayed inside the patient.When using the ar-2923bch suture anchor biocomposite hip pushlock, that anchor pulled out after insertion in one piece.Everything was removed from the patient.The third anchor was discarded, and no pictures were taken.The procedure was completed successfully, using a knotless fibertak anchor and a pushlock anchor with unknown product part numbers.The case was delayed for about 10 minutes, and no additional anesthesia was administered.This occurred during use with no reported patient harm.
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, prying/leveraging the device during insertion, and/or misaligned insertion.

• Brand Name: 3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK
• 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: 21315270
• Report Number: 1220246-2025-00224
• Device Sequence Number: 15507412
• Product Code: MAI
• UDI-Device Identifier: 00888867097193
• UDI-Public: (01)00888867097193(11)230807(17)250731(10)15125107
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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 Expiration Date: 07/31/2025
• Device Model Number: 3.0MM BIOCOMPOSITE KNOTLESS HIP S-TAK
• Device Catalogue Number: AR-1938BCH
• Device Lot Number: 15125107
• 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: 02/05/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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