MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,FASTAK II; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,FASTAK II
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
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.Observation revealed that the anchor was not present with the device, and the suture fiber was not contained inside.Because the anchor was not returned, complaint could not be confirmed.The most likely cause for the reported failure can be attributed to user error due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.- unrelated: observation revealed unknown discoloration along the shaft.- refer to photos #1-3.
Event or Problem Description
It was reported that during a bankart repair, the implant failed to anchor and fell out off the bone.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: SUTR ANCH,FASTAK II
• Common Device Name: SCREW, FIXATION, BONE
• 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: 19288726
• Report Number: 1220246-2024-03114
• Device Sequence Number: 21005773
• Product Code: HWC
• UDI-Device Identifier: 00888867010376
• UDI-Public: 00888867010376
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: 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: 02/28/2025
• Device Model Number: SUTR ANCH,FASTAK II
• Device Catalogue Number: AR-1324HF-1
• Device Lot Number: 10738444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown