MAUDE Adverse Event Report: 4WEB, INC. 4WEB ANTERIOR TRUSS SYSTEM; INTERBODY FUSION DEVICE INSERTER

Model Number	ASTS-000001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inserter was returned to 4web and analyzed.The broken thread was confirmed.Review of production records did not indicate any issues related to manufacturing that may have contributed to the event.Cause of thread breakage is unknown.It was reported that after the product was shipped by the manufacturer, the inserter was modified prior to use.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported to 4web that the tip of the alif inserter broke within the thread hole of the implant while the surgeon was trying to readjust the cage during surgery.Surgeon was unable to retrieve the broken piece of the inserter from the cage.No patient injury or death reported.Surgery was completed successfully.

• Brand Name: 4WEB ANTERIOR TRUSS SYSTEM
• Common Device Name: INTERBODY FUSION DEVICE INSERTER
• Manufacturer (Section D): 4WEB, INC.; 2801 network boulevard; suite 620; frisco TX 75034
• MDR Report Key: 10575406
• Report Number: 3009189869-2020-00013
• Device Sequence Number: 19130713
• Product Code: MAX
• UDI-Device Identifier: 00812998036202
• UDI-Public: 00812998036202
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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: ASTS-000001
• Device Catalogue Number: ASTS-000001
• Device Lot Number: A000AA012
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR