MAUDE Adverse Event Report: 4WEB, INC. 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE; STRAIGHT PUNCH AWL

Model Number	ASTS-SA-100006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken awl was returned to the manufacturer and analyzed.Production records were reviewed and no manufacturing deficiences were identified that could have contributed to this event.
Event or Problem Description
The tip of the straight punch awl used in surgery broke in the screw hole of the 4web anterior cage.It was reported that the anti-backout plate was engaged, however, due to the tip breaking, one of the three screws could not be implanted with the cage.The tip of the instrument was left in the patient since it could not be retrieved.Surgery was completed successfully.

• Brand Name: 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE
• Common Device Name: STRAIGHT PUNCH AWL
• Manufacturer (Section D): 4WEB, INC.; 2801 network boulevard; suite 620; frisco TX 75034
• MDR Report Key: 12510015
• Report Number: 3009189869-2021-00005
• Device Sequence Number: 19663623
• Product Code: HWJ
• UDI-Device Identifier: 00812998043903
• UDI-Public: 00812998043903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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-SA-100006
• Device Catalogue Number: ASTS-SA-100006
• Device Lot Number: 30394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR