MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. MULTI-AXIAL SCREW INSERTER; SCREWDRIVER

Catalog Number 14-500185

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown.Therefore the device history records are unable to be reviewed.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.

Event Description

It was reported that a pedicle screw was threaded partway into the vertebral body and became stuck intra-operatively.While the surgeon was trying to advance and back out the screw, the tulip head broke off the screw and the tip of the screwdriver broke off.The surgeon used alternative instrumentation to remove the screw.There was no impact on the patient; however, the procedure was delayed 60 minutes.This is report two of two for this event.

Manufacturer Narrative

If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.Reference report 3012447612-2023-00391.

Event Description

It was reported that a pedicle screw was threaded partway into the vertebral body and became stuck intra-operatively.While the surgeon was trying to advance and back out the screw, the tulip head broke off the screw and the tip of the screwdriver broke off.The surgeon used alternative instrumentation to remove the screw.There was no impact on the patient; however, the procedure was delayed 60 minutes.This is report two of two for this event.

• Brand Name: MULTI-AXIAL SCREW INSERTER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18310765
• MDR Text Key: 330283068
• Report Number: 3012447612-2023-00392
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: LH
• PMA/PMN Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 14-500185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic