MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. POLYAXIAL HEX SCREW DRIVER (2.5MM); SCREWDRIVER

Catalog Number	07.01764.002
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.
Event or Problem Description
It was reported that during surgery, a virage screwdriver fractured at the tip and a 5.5 mm 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 one of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun (02)" no longer applies but cannot be deleted.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.Inspection the returned device was examined.Visual inspection revealed the tip is fractured.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¿s control.Root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive or off-axis forces applied during use.Device usage this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.Reference report 3012447612-2024-00268.
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 one of two for this event.

• Brand Name: POLYAXIAL HEX SCREW DRIVER (2.5MM)
• 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: 20452810
• Report Number: 3012447612-2024-00267
• Device Sequence Number: 15593369
• Product Code: HXX
• UDI-Device Identifier: 00887868289095
• UDI-Public: (01)00887868289095(10)MS5801
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/16/2025

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: 07.01764.002
• Device Lot Number: MS5801
• 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: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic