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

Model Number	SUTURE ANCHOR, BIOCOMPO- SITE PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2024
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 employee via email that for an ar-1922bc, suture anchor, biocomposite pushlock anchor broke while pulling it out.This was detected during a rotator cuff repair procedure on (b)(6) 2024.Ar-1922p was used to prepare bone socket and the anchor broke while pulling it out.The broken pieces were left inside patient.Fragments were not retrieved.Procedure was successfully completed with no patient harm and no secondary procedure.
Additional Manufacturer Narrative
The complaint allegation is confirmed.Visual evaluation of the photo provided displays the broken tip of the anchor.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.Given that the bone quality of the patient was not provided the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; applying excessive forces or prying/leveraging the device during insertion.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1922bc, pushlock, serial/batch number (b)(6), was received for investigation.Visual inspection noted that the eyelet of the device was broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to improper bone prep, misaligned insertion, applying excessive force, or prying/leveraging the device during insertion.The complaint allegation is confirmed.

• Brand Name: SUTURE ANCHOR, BIOCOMPO- SITE 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: 21034138
• Report Number: 1220246-2024-09091
• Device Sequence Number: 3969641
• Product Code: MAI
• UDI-Device Identifier: 00888867022874
• UDI-Public: (01)00888867022874(11)240116(17)271231(10)15194025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082810
• 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): 04/21/2025

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, BIOCOMPO- SITE PUSHLOCK
• Device Catalogue Number: AR-1922BC
• Device Lot Number: 15194025
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 04/17/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/05/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2024
• 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