MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. T27 FINAL DRIVER; SCREWDRIVER

Catalog Number	730M0017
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that the tips of two vital t27 final drivers fractured during surgery and a torque limiting handle took more force than usual to torque.The first broken tip of the set screwdriver was retrieved, but the second tip remained in the set screw in the patient body.A 30 minute delay to the surgery was also reported.This is report one of three for this event.
Additional Manufacturer Narrative
Corrections in d4: lot number, d9, and h3.Additional information in d4: udi number, and h4.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference reports 3012447612-2024-00243 through 3012447612-2024-00245.
Event or Problem Description
It was reported that the tips of two vital t27 final drivers fractured during surgery and a torque limiting handle took more force than usual to torque.The first broken tip of the set screwdriver was retrieved, but the second tip remained in the set screw in the patient body.A 30 minute delay to the surgery was also reported.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.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip is twisted and fractured off.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or applying excessive torque to the driver during use.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and 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.
Event or Problem Description
It was reported that the tips of two vital t27 final drivers fractured during surgery and a torque limiting handle took more force than usual to torque.The first broken tip of the set screwdriver was retrieved, but the second tip remained in the set screw in the patient body.A 30 minute delay to the surgery was also reported.This is report one of three for this event.
Event or Problem Description
It was reported that the tips of two vital t27 final drivers fractured during surgery and a torque limiting handle took more force than usual to torque.The first broken tip of the set screwdriver was retrieved, but the second tip remained in the set screw in the patient body.A 30 minute delay to the surgery was also reported.This is report one of three for this event.
Additional Manufacturer Narrative
Corrections in h6: conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the tip is twisted and fractured off.Root cause: a definitive root cause could not be determined, but the associated torque handle was found to be inoperable, leading to excessive forces applied to the driver during use.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and 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: T27 FINAL 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: 20148548
• Report Number: 3012447612-2024-00243
• Device Sequence Number: 8397490
• Product Code: HXX
• UDI-Device Identifier: 00880304852761
• UDI-Public: (01)00880304852761(10)309622A
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/26/2025

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: 730M0017
• Device Lot Number: 309622A
• Was Device Available for Evaluation?: Yes
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/04/2024; 01/15/2025; 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2017
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic