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

Model Number	SUTURE ANCHOR, MINI BIO-PUSHLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 7/26/2024, it was reported by an arthrex subsidiary employee via email that an ar-8825b mini bio-pushlock eyelet came off the inserter.The case was completed using a new ar-8825b mini bio-pushlock.This was discovered during a tfcc repair procedure on (b)(6) 2024.The case was not delayed, and the patient suffered no harm.Additional information received on 8/1/2024: pushlock eyelet broke off in the patient and it was successfully retrieved.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is confirmed.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 due to misalignment and/or prying/leveraging the device during insertion.

• Brand Name: SUTURE ANCHOR, MINI BIO-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: 19937791
• Report Number: 1220246-2024-07086
• Device Sequence Number: 4929181
• Product Code: MAI
• UDI-Device Identifier: 00888867046641
• UDI-Public: 00888867046641
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173240
• 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): 11/25/2024

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, MINI BIO-PUSHLOCK
• Device Catalogue Number: AR-8825B
• Device Lot Number: 15155331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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