MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, an fda medwatch notification was received via email.A facility representative reported that an ar-2923bc biocomposite pushlock sl anchor was found defective and broke off prior to implantation in the patient's shoulder.The surgeon turned off the outflow, and upon further assessment, the anchor could no longer be found.The patient's shoulder was searched for the anchor.The anchor was unable to be obtained, and a new anchor was opened.It was documented that the anchor was implanted, as it remained within the shoulder.This was discovered during a procedure in (b)(6) 2024.No further information was provided.Additional information received on 1/20/2025: this was discovered during a right shoulder arthroscopic, anterior labral repair, and slap repair procedure on (b)(6) 2024.The new anchor used to complete the case was also an ar-2923bc biocomposite pushlock sl.The case was not delayed, and additional anesthesia was not needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d6a, g3, h3, h6.The complaint device was not received for evaluation.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 concluded that the most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.The complaint allegation was not confirmed, and no evidence of the failure was received.

• Brand Name: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• 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: 21305118
• Report Number: 1220246-2025-00162
• Device Sequence Number: 8214228
• Product Code: MAI
• UDI-Device Identifier: 00888867099203
• UDI-Public: (01)00888867099203(11)240730(17)260630(10)15295117
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 06/30/2026
• Device Model Number: SUTR ANCH,BIO-COMP P-LCK,2.9X 12.5MM
• Device Catalogue Number: AR-2923BC
• Device Lot Number: 15295117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2024
• 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