MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. VIRAGE NAV D2.3MM DRILL BIT; VIRAGE NAVIGATION SYSTEM

Catalog Number	130P2023
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.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 virage navigation drill bit was worn and dull.It was used to complete the procedure without patient impact.
Event or Problem Description
It was reported that a virage navigation drill bit was worn and dull.It was used to complete the procedure without patient impact.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in g1 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed no signs of damage.A functional inspection was performed with an array (131t2002 lot 314645) and found the drill bit was able to mate with and release from the array, however only with force.Additionally, the drill bit was able to spin freely while connected to the array.A dimensional inspection of the shaft was performed with a micrometer (id: eq-0899 cal.Due 3/20/2025) and found the dimension to be as high as 7.875mm, which is the high limit per drawing number 130p2023-a1 revision 04.The dimension should be 7.865 +/- 0.010.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.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: VIRAGE NAV D2.3MM DRILL BIT
• Common Device Name: VIRAGE NAVIGATION 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: 19696869
• Report Number: 3012447612-2024-00149
• Device Sequence Number: 15484415
• Product Code: OLO
• UDI-Device Identifier: 00887868517044
• UDI-Public: (01)00887868517044(10)480602
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K212023
• 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): 12/16/2024

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: Health Professional
• Device Catalogue Number: 130P2023
• Device Lot Number: 4480602
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2024
• 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
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2024
• 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