MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. CAPTIVE HEX SCREWDRIVER 4MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	ET1052-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a distributor discovered a captive hex driver, a polaris button lock screw inserter, and a polaris multi-axial screw inserter all with fractured tips after they were returned from the field.No patient or clinical information was provided with the return.This is report one 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.
Event or Problem Description
It was reported that a distributor discovered a captive hex driver, a polaris button lock screw inserter, and a polaris multi-axial screw inserter all with fractured tips after they were returned from the field.No patient or clinical information was provided with the return.This is report one of three for this event.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip is fractured.Root cause: this event could possibly be attributed to wear through multiple uses over time or off-axis forces applied during use.Dhr review: the dhr could not be located, therefore a dhr review could not be completed.Device usage: 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 3012447612-2025-00210 through 3012447612-2025-00212.

• Brand Name: CAPTIVE HEX SCREWDRIVER 4MM
• 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: 22026726
• Report Number: 3012447612-2025-00210
• Device Sequence Number: 12567695
• Product Code: NKB
• UDI-Device Identifier: 00889024339316
• UDI-Public: (01)00889024339316(10)L543700
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133086
• 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,Followup
• Report Date (Section B): 08/07/2025

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: ET1052-01
• Device Lot Number: L543700
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2025
• 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: 05/15/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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