MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITAL MIS POLYAXIAL SCREW, 5.5X45MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	824M5545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
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 one 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 report 3012447612-2022-00204.
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 one of three for this event.

• Brand Name: VITAL MIS POLYAXIAL SCREW, 5.5X45MM
• 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: 15314828
• Report Number: 3012447612-2022-00202
• Device Sequence Number: 12106031
• Product Code: NKB
• UDI-Device Identifier: 00887868513411
• UDI-Public: (01)00887868513411(10)SBM136316
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 824M5545
• Device Lot Number: SBM136316
• 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: 11/27/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG