MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
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) 2024, it was reported by an arthrex subsidiary employee via email that an ar-1926bc biocomposite push lock screw broke during insertion.All the broken fragments were removed, and the case was completed using a new ar-1926bc biocomposite pushlock.This was discovered during an rcr procedure on (b)(6) 2024.The case as not delayed, and additional anesthesia was not needed.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed based off the customer-provided photo.Visual evaluation revealed the tip of the device is broken off.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 upon insertion.
Additional Manufacturer Narrative
Additional information: g3.Complaint allegation is confirmed.One unpackaged ar-1926bc biocomposite pushlock was received for investigation.Visual evaluation of the returned device noted that the anchor was damaged, it was bent and had fractured.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 applying excessive mechanical forces during insertion, prying/leveraging the device during use and/or misaligned insertion.

• Brand Name: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• 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: 20156184
• Report Number: 1220246-2024-07409
• Device Sequence Number: 4247702
• Product Code: MAI
• UDI-Device Identifier: 00888867023239
• UDI-Public: 00888867023239
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101679
• 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,Followup
• Report Date (Section B): 06/02/2025

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: SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK
• Device Catalogue Number: AR-1926BC
• Device Lot Number: 15183215
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 05/13/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 12/30/2024; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2023
• 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