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

Catalog Number 730M0017

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2024

Event Type  malfunction  

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 Description

It was reported that during a surgery, three vitality drivers fractured when trying to remove a stuck iliac screw.The screw was ultimately able to be removed and replaced with a shorter screw.This resulted in a 20 minute delay to the procedure but no other patient impact.This is report one of four for this event.

• Brand Name: T27 FINAL DRIVER
• Type of Device: 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18584881
• MDR Text Key: 333927657
• Report Number: 3012447612-2024-00008
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00880304852761
• UDI-Public: (01)00880304852761(10)309620
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 730M0017
• Device Lot Number: 309620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic