MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. UNIVERSAL DRIVER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	2155-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 the tips of three screw drivers (one universal and two universal with standard connections) broke intra-operatively while attempting to remove a screw that had been implanted for 16 years.The screw was able to be removed using an alternative method since the driver engagement feature had stripped.There were no reported impacts to the patient.This is report one of three for this event.
Event or Problem Description
It was reported that the tips of three screw drivers (one universal and two universal with standard connections) broke intra-operatively while attempting to remove a screw that had been implanted for 16 years.The screw was able to be removed using an alternative method since the driver engagement feature had stripped.There were no reported impacts to the patient.This is report one of three for this event.
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 one of the prongs on the tip of the device has fractured.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for driver for the failure of fracture.The failure could possibly be attributed to excessive forces being applied beyond intended use.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.Reference reports 3012447612-2025-00399 through 3012447612-2025-00401.

• Brand Name: UNIVERSAL DRIVER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 23871615
• Report Number: 3012447612-2025-00399
• Device Sequence Number: 17281188
• Product Code: NKB
• UDI-Device Identifier: 00889024398993
• UDI-Public: (01)00889024398993(10)48PD
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K132884
• 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): 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: 2155-1
• Device Lot Number: 48PD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/03/2025
• 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: 12/22/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2008
• 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: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic