MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITAL MIS T27 FINAL DRIVER LONG; SCREWDRIVER

Catalog Number	850M0025
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
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 a vital mis driver stripped intra-operatively.The surgery was completed with another driver.There are no adverse events or patient impacts reported.
Additional Manufacturer Narrative
Corrections in d4: lot number, udi number, d9, and h3.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 a vital mis driver stripped intra-operatively.The surgery was completed with another driver.There are no adverse events or patient impacts reported.
Additional Manufacturer Narrative
Corrections in g1 and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed the tip of the driver has minor material displacement from use.A functional inspection was performed with a vital screw (pn824m5555 lot sbm135466) and found the driver was able to mate with the screw as expected.Root cause: a definitive root cause cannot be determined as the returned device was found to function as expected.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 a vital mis driver stripped intra-operatively.The surgery was completed with another driver.There are no adverse events or patient impacts reported.

• Brand Name: VITAL MIS T27 FINAL DRIVER LONG
• 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.; na; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16994408
• Report Number: 3012447612-2023-00173
• Device Sequence Number: 3455282
• Product Code: HXX
• UDI-Device Identifier: 00887868310188
• UDI-Public: (01)00887868310188(10)MC4398306
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 06/24/2024

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
• Operator of Device: Other
• Device Catalogue Number: 850M0025
• Device Lot Number: MC4398306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 05/25/2023; Not provided
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/12/2023; 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic