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

Catalog Number 801M5545

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Malunion of Bone (4529)

Event Date 08/18/2021

Event Type  Injury  

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 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 three of three for this event.

Event 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 three of three for this event.

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.

• Brand Name: CANNULATED POLYAXIAL SCREW 5.5X45MM
• Type of Device: VITALITY SPINAL FIXATION SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12470947
• MDR Text Key: 271379042
• Report Number: 3012447612-2021-00357
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887868254796
• UDI-Public: (01)00887868254796(10)T10396
• Combination Product (y/n): N
• PMA/PMN Number: K183550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 183