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	03/21/2024
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 04/11/2024, it was reported by an arthrex employee via email that an ar-1920sf corkscrew anchor broke during insertion.All the broken fragments were removed successfully.The case was completed using another ar-1920sf corkscrew.This was discovered during a collateral ligament injury repair procedure on (b)(6) 2024.The patient suffered no negative effects.Additional information received on 4/23/2024: the case was delayed ten minutes; additional anesthesia was not needed.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the damage observed on the returned device.One unpackaged ar-1920sf was received for investigation.The anchor was not received with the returned device.Visual evaluation of the device under a magnifier noted that the tip of the cannulated driver had slight damage.Functional testing was not performed due to the missing components.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces upon insertion and/or improper bone preparation.Refer to investigation photos.

• 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: jared engle ; 8009337001
• MDR Report Key: 19239913
• Report Number: 1220246-2024-02772
• Device Sequence Number: 12771149
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Model Number: SUTURE ANCHOR, CORKSCREW
• Device Catalogue Number: AR-1920SF
• Device Lot Number: 15145063
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• 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