MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ELBOW TORQUE DRIVER

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 08/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As there was no device available at the surgery, no device will be returned.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? no device.

Event Description

It was reported during surgery the disposable driver instrument was not ordered and the surgeon was unable to complete the surgery as intended.The patient wound was closed up after a 45 minute delay to surgery without the elbow being locked.No revision has been scheduled at this time.No further information available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g4, g7, h1, h2, h3, h6, h10.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

Event Description

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

• Brand Name: ELBOW TORQUE DRIVER
• Type of Device: DRIVER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8929955
• MDR Text Key: 155486319
• Report Number: 0001822565-2019-03512
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• 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: 02/27/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00840108000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention