MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CANNULATED POLYAXIAL REDUCTION SCREW 7.5X45MM; VITALITY SPINAL FIXATION SYSTEM

Catalog Number	824M7545
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a cannulated pedicle screw would not slide down a k-wire smoothly intra-operatively.Another screw of the same size was used to complete the procedure without patient impacts.Device evaluation by the manufacturer found the screw's tip was bent/deformed.
Additional Manufacturer Narrative
Device evaluation the screw (824m7545) has minor deformation damage on the tip of the screw shank.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: CANNULATED POLYAXIAL REDUCTION SCREW 7.5X45MM
• 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: 13025587
• Report Number: 3012447612-2021-00477
• Device Sequence Number: 1893853
• Product Code: NKB
• UDI-Device Identifier: 00887868514258
• UDI-Public: (01)00887868514258(10)SBM137954
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K203507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2021

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: 824M7545
• Device Lot Number: SBM137954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• 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: 12/16/2021
• Initial Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• 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
• Patient Sex: Unknown