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 Code	Foreign Body In Patient (2687)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/12/2023, an fda medwatch notification was received via email.A facility representative reported that an ar-1923ps peek pushlock anchor broke inside the patient.The surgeon was unable to retrieve all the broken fragments.This was discovered during a surgical repair procedure on (b)(6) 2023.Additional information requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or applying excessive mechanical forces upon insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17908389
• Report Number: 1220246-2023-08126
• Device Sequence Number: 8224773
• Product Code: HWC
• UDI-Device Identifier: 00888867023147
• UDI-Public: 00888867023147
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 15021669
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2022
• 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