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

Model Number	SUTURE ANCHOR, CORKSCREW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 11/06/2023, it was reported by an arthrex subsidiary employee via email that an ar-1920sf corkscrew anchor broke.This was discovered during a right knee arthroscopy and clean-up procedure on 4//11/2023.The case was completed by removing all broken fragments and using another ar-1920sf corkscrew.Additional information was received on 11/20/2023: the case was delayed for fifteen minutes, but no additional anesthesia was needed.The patient suffered no negative effects on or after the surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Complaint allegation is not confirmed.Visual evaluation identified that the driver was returned without implant, and sutures.No broken pieces of the implant were returned for investigation.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTURE ANCHOR, CORKSCREW
• 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: 18331152
• Report Number: 1220246-2023-09373
• Device Sequence Number: 8424903
• Product Code: HWC
• UDI-Device Identifier: 00888867022829
• UDI-Public: 00888867022829
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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 Expiration Date: 09/30/2025
• Device Model Number: SUTURE ANCHOR, CORKSCREW
• Device Catalogue Number: AR-1920SF
• Device Lot Number: 11857330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown