MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL SCREW (DIA. 5.5 MM X 35 MM L); VIRAGE OCT SPINAL FIXATION SYSTEM

Catalog Number	07.01708.021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10: 07.01764.003, virage oct polyaxial screw driver, outer sleeve, lot s5802 x2 ; 07.01764.001, virage oct polyaxial screw driver, inner sleeve, lots ms5800 and 62874317 ; unknown virage rod ; closure top 07.01728.001 lot t12097.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.Reference report 3012447612-2024-00267.
Event or Problem Description
It was reported that during surgery, a virage screwdriver fractured at the tip and a 5.5mm diameter virage screw broke apart at the tulip head.The procedure was completed with additional screw drivers and screws in their set.There was no patient impact; however, there was a 10-15 minute delay to grab new screw drivers and screw.This is report two of two for this event.
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 lower housing has fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.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 during surgery, a virage screwdriver fractured at the tip and a 5.5mm diameter virage screw broke apart at the tulip head.The procedure was completed with additional screw drivers and screws in their set.There was no patient impact; however, there was a 10-15 minute delay to grab new screw drivers and screw.This is report two of two for this event.

• Brand Name: POLYAXIAL SCREW (DIA. 5.5 MM X 35 MM L)
• Common Device Name: VIRAGE OCT SPINAL FIXATION 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: 20452819
• Report Number: 3012447612-2024-00268
• Device Sequence Number: 8497397
• Product Code: KWP
• UDI-Device Identifier: 00889024328389
• UDI-Public: (01)00889024328389(10)AAD
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133556
• 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): 04/27/2025

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: 07.01708.021
• Device Lot Number: AAD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2024
• 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: 10/15/2024
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic