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

Model Number	SUTURE ANCHOR, PEEK PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Foreign Body In Patient (2687)
Date of Event	11/25/2024
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
It was reported that during an arthroscopic labral reconstruction surgery one of the tip's of the pushlocker anchors ar-2324pslc (lot: 15136825) and ar-1923ps (lot: 15236451 & 15151614) broke and became embedded in patients shoulder.Surgeon checked from another portal and attempted to retrieve the broken off part using a grasper which was not possible and there was a greater risk to remove the tip.The fragment remained in side the patient.No further in formation was provided.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause of the reported failure is user error, specifically improper bone preparation, misalignment of the insertion and/or excessive force during insertion.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.
Event or Problem Description
On (b)(6) 2025 it was confirmed that it is unclear which device broke, due to no documentation.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Correction: d2a.

• Brand Name: SUTURE ANCHOR, PEEK 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: 21048550
• Report Number: 1220246-2024-09154
• Device Sequence Number: 8372644
• Product Code: MBI
• UDI-Device Identifier: 00888867023147
• UDI-Public: (01)00888867023147(11)231009(17)280930(10)15151614
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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, PEEK PUSHLOCK
• Device Catalogue Number: AR-1923PS
• Device Lot Number: 15151614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 06/09/2025; Not provided
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 07/03/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• 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