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

Catalog Number	07.02054.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
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 during a surgery, the tip of a final vital driver fractured.This resulted in a 20 minute delay and they were unable to retrieve the fractured tip.The surgery was completed using other instruments and there was no patient impact beyond the tip retention.
Event or Problem Description
It was reported that during a surgery, the tip of a final vital driver fractured.This resulted in a 20 minute delay and they were unable to retrieve the fractured tip.The surgery was completed using other instruments and there was no patient impact beyond the tip retention.
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.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip has twisted and fractured.Root cause: a definitive root cause could not be determined, but excessive torsional forces applied to the driver during use could cause the tip to deform and fracture.Dhr review: the dhr was reviewed.There was one non-conformance associated with this lot related to supplier documentation.The correct documentation was provided and the devices re-inspected.The device was likely conforming when it left highridge medical's control.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.

• Brand Name: SCREW DRIVER, STANDARD
• 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: 21595482
• Report Number: 3012447612-2025-00098
• Device Sequence Number: 18373959
• Product Code: NKB
• UDI-Device Identifier: 00889024009806
• UDI-Public: (01)00889024009806(10)AB96
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K150896
• 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): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07.02054.001
• Device Lot Number: AB96
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2025
• 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: 03/13/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic