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	11/30/2023
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 1/2/2024, it was reported by an arthrex subsidiary employee via email that an ar-1920sf corkscrew anchor broke during insertion.The broken fragments were removed and the case was completed using another ar-1920sf corkscrew anchor.This was discovered during an rcr procedure on (b)(6) 2023.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Complaint is confirmed.Visual inspection identified the screw hex edges of the suture anchor, corkscrew® 5 mm x 15.5 mm with #2 fiberwire® and #2 tiger wire® had rounded/stripped.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the driver within the screw during use.
Event or Problem Description
Additional information was provided on 01/15/2024, where it was reported by the arthrex subsidiary employee that the patient had normal bone quality.The case was delayed 30 minutes, and no additional anesthesia was administered.

• 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: 18553165
• Report Number: 1220246-2024-00455
• Device Sequence Number: 20435977
• 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): 08/28/2024

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: 15053301
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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