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

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)/2023, it was reported by a sales representative via email that an ar-1318ft corkscrew ft anchor was not attached to the inserter.The surgeon attempted to load the anchor back on, but it began to strip.Another ar-1318ft corkscrew ft was opened from the same lot number and did not have the anchor attached to the inserter either.The surgeon tried reattaching it, but the sutures pulled out of the anchor.The case was completed with a combination of sutures and products from another manufacturer.This was discovered during a joint capsule repair procedure on (b)(6)2023.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.The complaint allegation is confirmed based on the customer provided picture, which shows the detached frayed suture as well as the detached anchor separated from the inserter.Indicating that the frayed suture pulled out of the anchor.The most likely cause for the reported failure can be attributed error user due to improper bone prep; misaligned insertion and/or prying/leveraging the device during insertion.No picture was provided for the second device.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• 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: 17442574
• Report Number: 1220246-2023-07394
• Device Sequence Number: 2493942
• Product Code: HWC
• UDI-Device Identifier: 00888867008519
• UDI-Public: 00888867008519
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 11/30/2024
• Device Model Number: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT
• Device Lot Number: 10484206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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