MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPREHENSIVE INSTRUMENTATION CENTRAL SCREW DRILL BIT; EXTREMITIES, INSTRUMENT

Catalog Number 405883

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that during the procedure, the baseplate was impacted, the surgeon attempted to insert the central screw.The screw would not advance through the central hole in the baseplate.A different screw size was then attempted to be inserted but then was also hung up and would not go through.Surgeon then used central drill to see if original hole was issue.The screw would not advance again after using the drill.Surgeon could not insert a central screw and just placed 4 peripheral screws to complete the procedure.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPREHENSIVE INSTRUMENTATION CENTRAL SCREW DRILL BIT
• Type of Device: EXTREMITIES, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8863703
• MDR Text Key: 153352884
• Report Number: 0001825034-2019-03443
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405883
• Device Lot Number: 605920
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention