MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITAL MIS PAT CANNULATED TAP 4.5MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	850M6045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report three of three for this event.
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.Reference reports 3012447612-2022-00202.
Event or Problem Description
It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report three of three for this event.
Additional 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.
Additional Manufacturer Narrative
Device evaluation visual inspection revealed that the tip of the screw was fractured off, and the tips of both cannulated taps were fractured.Potential cause root cause was unable to be determined.This event could possibly be attributed to inserting the screw without tapping initially, or due to sclerotic bone.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported while inserting the 5.5mm x 45mm screw at t10 right side without tapping, the screw broke.Right after this, both 4.5mm taps broke when drilling a pilot hole on the right side of l2/l3 vertebral body.The broken screw remains implanted within the patient body.The taps were able to be removed using extra instruments.The patient has new leg pain when lying down and sitting post-operatively.The procedure was delayed two hours due to the breakage, removal, and re-inserting the screws.This is report three of three for this event.

• Brand Name: VITAL MIS PAT CANNULATED TAP 4.5MM
• Common Device Name: VITALITY 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.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15314857
• Report Number: 3012447612-2022-00204
• Device Sequence Number: 5287442
• Product Code: NKB
• UDI-Device Identifier: 00887868459030
• UDI-Public: (01)00887868459030(10)4481205
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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: 850M6045
• Device Lot Number: 4481205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 10/12/2022; 11/27/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/04/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG