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

Catalog Number	230H4001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three tether set screw driver tips fractured at different points during a surgical procedure.There was no patient impact, all pieces were retrieved, and a fourth driver was used to complete the surgery.This is report three of three for this event.
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.Reference reports 3012447612-2025-00404.
Event or Problem Description
It was reported that three tether set screw driver tips fractured at different points during a surgical procedure.There was no patient impact, all pieces were retrieved, and a fourth driver was used to complete the surgery.This is report three 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 the tip is fractured.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for tether driver for the failure of fracture.The failure could possibly be attributed to the repeated usage and/or excessive forces being applied beyond the intended use of the instrument leading to the 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: SET SCREW 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: 23880825
• Report Number: 3012447612-2025-00406
• Device Sequence Number: 9464739
• Product Code: HXX
• UDI-Device Identifier: 03662663161442
• UDI-Public: (01)03662663161442(10)313772
• 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,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: 230H4001
• Device Lot Number: 313772
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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: Female
• Patient Ethnicity: Non Hispanic