MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, PUSHLOCK; BONE FIXATION SCREW/PLATE

Model Number	SUTURE ANCHOR, PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 2nd july 2025, it was reported by an arthrex's employee via email that for an ar-1922ps, suture anchor, pushlock® 4.5 x 24 mm, its anchor broke when suturing.This was detected during a reconstruction of the cruciate ligament procedure on (b)(6) 2025.The procedure was completed successfully by using another new ar-1922ps.There was no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.-one unpackaged ar-1922ps was received for investigation.-visual inspection of the suture anchor, pushlock® 4.5 x 24 mm, identified that the tip of the eyelet was broken off.-functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error of the device due to misalignment, insertion, and/or prying/leveraging of the device during insertion.-refer to investigation photos.-complaint allegation is confirmed.

• Brand Name: SUTURE ANCHOR, PUSHLOCK
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 22589067
• Report Number: 1220246-2025-03055
• Device Sequence Number: 9005116
• Product Code: MBI
• UDI-Device Identifier: 00888867022959
• UDI-Public: (01)00888867022959(11)250127(17)291231(10)15378410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061863
• 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): 09/25/2025

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, PUSHLOCK
• Device Catalogue Number: AR-1922PS
• Device Lot Number: 15378410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 07/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown