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

Catalog Number	07.02063.001
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr was conducted and found no indications of manufacturing issues.The device was manufactured in 2021.An inspection of the part shows the tip is twisted and fractured.This event likely cannot be attributed to manufacturing or design related issues.The failure could possibly be attributed to the repeated usage and/or high torque of the instrument leading to the deformation and fracture of the device.The complaint is confirmed for t20 final driver vitality (07.02063.001) for the failure of deformation and fractured tip.This device is used for treatment.
Event or Problem Description
A distributor reported that three vitality and one polaris inserter had become worn through repeated usage.This was not associated with a particular surgery.The manufacturer investigation was completed and found the tip of one of the drivers is fractured.

• 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: 24315459
• Report Number: 3012447612-2026-00049
• Device Sequence Number: 11977588
• Product Code: HXX
• UDI-Device Identifier: 00889024009875
• UDI-Public: (01)00889024009875(10)4441301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 4441301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic