MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; BONE FIXATION SCREW/PLATE

Model Number	SUTR ANCH,CRKSCRW
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 06/6/2024 it was reported by an arthrex subsidiary employee via email that an ar-1920nsf corkscrew pulled out.The case was completed using another ar-1920nsf corkscrew.This was discovered during a shoulder arthroplasty procedure on (b)(6) 2024.Additional information was provided on 06/11/2024, where the arthrex subsidiary employee stated another ar-1920nsf corkscrew was used to complete the case.The suture did break and the fragments were retrieved.The patient had a regular bone quality.This resulted in a 10-minute delay.There was no additional anesthesia administered and there wasn't any negative effect on the patient.
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 method of bone preparation was not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: SUTR ANCH,CRKSCRW
• 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: 19666452
• Report Number: 1220246-2024-06566
• Device Sequence Number: 17848135
• Product Code: HWC
• UDI-Device Identifier: 00888867022751
• UDI-Public: 00888867022751
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1920NSF
• Device Lot Number: 15167403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown