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

Model Number	SUTURE ANCHOR, PEEK MINI PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/28/2023, it was reported by a distributor via email that an ar-8825p peek mini pushlock anchor broke during insertion.This was discovered during a procedure on (b)(6) 2023.Additional information received on 3/31/2023: this was discovered during an internal intercarpal brace procedure and was completed using another ar-8825p peek mini pushlock.All of the broken fragments were retrieved from inside the patient.
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 misuse due to improper bone preparation; misaligned insertion; or prying/leveraging the device during insertion.

• Brand Name: SUTURE ANCHOR, PEEK MINI 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: vik bajnath ; 8009337001
• MDR Report Key: 16814952
• Report Number: 1220246-2023-06590
• Device Sequence Number: 14886484
• Product Code: HWC
• UDI-Device Identifier: 00888867046672
• UDI-Public: 00888867046672
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K063479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 MINI PUSHLOCK
• Device Catalogue Number: AR-8825P
• Device Lot Number: 14977578
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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