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

Catalog Number	801M5545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Malunion of Bone (4529)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
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.Reference reports 3012447612-2021-00355 through 3012447612-2021-00357.
Event or Problem Description
It was reported a revision surgery was performed to address post-op screw breakage and malunion.Prior to the revision, the surgeon thought one screw was broken, but three screws were found to be broken during the revision.The shafts of the three screws were unable to be removed and remain implanted within the patient.No new hardware was added during the revision.This is report two of three for this event.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the returned devices were examined.Visual inspection revealed that three of the four returned screws are fractured.Dhr review: the dhrs were reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they left zimmer biomet¿s control.Potential root cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the screws were installed during the initial surgery.Device use: these devices are 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 a revision surgery was performed to address post-op screw breakage and malunion.Prior to the revision, the surgeon thought one screw was broken, but three screws were found to be broken during the revision.The shafts of the three screws were unable to be removed and remain implanted within the patient.No new hardware was added during the revision.This is report two of three for this event.

• Brand Name: CANNULATED POLYAXIAL SCREW 5.5X45MM
• Common Device Name: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12470909
• Report Number: 3012447612-2021-00356
• Device Sequence Number: 11975204
• Product Code: NKB
• UDI-Device Identifier: 00887868254796
• UDI-Public: (01)00887868254796(10)T10396
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K183550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 801M5545
• Device Lot Number: T10396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 183