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

Model Number	ASTS-000002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inserter was returned to 4web and analyzed.The broken thread was confirmed.Dimensional analysis of the inserter confirmed that it met design specifications.Cause of thread breakage is unknown.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 during implantation.The broken piece of the inserter remained in the implant and was not retrieved since the surgeon believed it was better to leave the implant in place than to remove it.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
• MDR Report Key: 9813763
• Report Number: 3009189869-2020-00002
• Device Sequence Number: 19274243
• Product Code: MAX
• UDI-Device Identifier: 00812998036219
• UDI-Public: 00812998036219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112316
• 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): 03/10/2020

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-000002
• Device Catalogue Number: ASTS-000002
• Device Lot Number: VM14537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR