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

Model Number	SUTURE ANCHOR, CORKSCREW FT II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
On 8/26/2021 it was reported by a distributor via email that an ar-1928sf-2 suture anchor, corkscrew® ft ii 5.5 mm x 16.3 mm with #2 fiberwire® and #2 tigerwire® broke at the base of the titanium anchor.This was discovered during a procedure on (b)(6) 2021.No patient affected.Additional info received 9/15/2021 while doing a rcr the titanium anchor broke and suture broke while knotting the threats to fix anchor.Surgeon used another anchor to tie part of the anchor threads.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT II
• 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: 19288536
• Report Number: 1220246-2024-03112
• Device Sequence Number: 12933309
• Product Code: HWC
• UDI-Device Identifier: 00888867023703
• UDI-Public: 00888867023703
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2024

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: 05/31/2026
• Device Model Number: SUTURE ANCHOR, CORKSCREW FT II
• Device Catalogue Number: AR-1928SF-2
• Device Lot Number: 13488274
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown