MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. NAVIGATION CANNULATED T27 BONE SCREW DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	854M0021
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
Event or Problem Description
It was reported that when putting in iliac screws, the tip of a vital navigation driver twisted.The surgery was completed with a backup, and there was no reported patient harm.
Event or Problem Description
It was reported that when putting in iliac screws, the tip of a vital navigation driver twisted.The surgery was completed with a backup, and there was no reported patient harm.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.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 complaint is confirmed for vital navigation driver for the failure of deformation and fracture.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.This device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: NAVIGATION CANNULATED T27 BONE SCREW DRIVER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 23609992
• Report Number: 3012447612-2025-00368
• Device Sequence Number: 15753880
• Product Code: OLO
• UDI-Device Identifier: 03662663248679
• UDI-Public: (01)03662663248679(10)194140
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K191722
• 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,Followup
• Report Date (Section B): 04/09/2026

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: 854M0021
• Device Lot Number: 194140
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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