MAUDE Adverse Event Report: 4WEB, INC. 4WEB OSTEOTOMY TRUSS SYSTEM; OSTEOTOMY INSERTER

Model Number	UOTS-000002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The inserter was returned to 4web and analyzed visually.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.If additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported to 4web that the tip of uots inserter broke within the thread hole of the implant while malleting the implant into position.The broken piece of the inserter remained in the implant and was not retrieved.No patient injury or death reported.Surgery was completed successfully.

• Brand Name: 4WEB OSTEOTOMY TRUSS SYSTEM
• Common Device Name: OSTEOTOMY INSERTER
• Manufacturer (Section D): 4WEB, INC.; 2801 network boulevard; suite 620; frisco TX 75034
• Manufacturer (Section G): 4WEB, INC.; 2801 network boulevard; suite 620; frisco TX 75034
• Manufacturer Contact: upasana veturi ; 2801 network boulevard; suite 620; frisco, TX 75034 ; 8002857090
• MDR Report Key: 13372900
• Report Number: 3009189869-2022-00002
• Device Sequence Number: 4494152
• Product Code: HRS
• UDI-Device Identifier: 00812998033966
• UDI-Public: (01)00812998033966(10)C5079
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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: UOTS-000002
• Device Catalogue Number: UOTS-000002
• Device Lot Number: C5079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male