MAUDE Adverse Event Report: ARTHREX, INC. 8MM FLEX DRILL, KNOTLESS HIP FIBERTAK; DRILL BIT

Model Number	8MM FLEX DRILL, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.
Event or Problem Description
On 12/16/2021 it was reported by a sales representative via sems that three ar-3602h anchors pulled out of the bone during a hip arthroscopy.The first one pulled out of the bone when it was set.It was replaced and the same event occurred.A third anchor was used but once again pulled out.The anchors were replaced with a non arthrex products and the case was completed with no further issues.The case involved a 32 year old female and, as of today she is fine.The rep is also returning the ar-3600nd-2h drill bit to be inspected also.

• Brand Name: 8MM FLEX DRILL, KNOTLESS HIP FIBERTAK
• Common Device Name: DRILL BIT
• 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: 19380435
• Report Number: 1220246-2024-03697
• Device Sequence Number: 7618899
• Product Code: HTW
• UDI-Device Identifier: 00888867298026
• UDI-Public: 00888867298026
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 07/31/2026
• Device Model Number: 8MM FLEX DRILL, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3600ND-2H
• Device Lot Number: 13855059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female