MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. FINAL DRIVER; SCREWDRIVER

Catalog Number	07.02063.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra-operatively, a vitality t20 final driver tip did not fit into crosslink screws.An additional t20 driver was used to complete the surgery and there was no patient impact.Upon manufacturer investigation, it was discovered that the tip of the driver was deformed.
Additional Manufacturer Narrative
A review of the dhr was conducted and found no indications of manufacturing issues.A visual inspection revealed deformation of the tip.A functional inspection was performed with a vitality transverse connector which revealed the tip of the driver is unable to mate with the screws of the connector.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for vitality t20 final driver for the failure of tip deformation and mating issues.This device is used for treatment.The failure could possibly be attributed to the repeated usage and/or excessive forces being applied to the instrument leading to the tip deformation and mating issues of the device.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: FINAL DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 24677198
• Report Number: 3012447612-2026-00081
• Device Sequence Number: 15989820
• Product Code: HXX
• UDI-Device Identifier: 03662663125536
• UDI-Public: (01)03662663125536(10)MC4245101
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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 Catalogue Number: 07.02063.001
• Device Lot Number: MC4245101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2017
• 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: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic