MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ULTRA-DRIVE III CONSOLE; DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT

Model Number	N/A
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
Event or Problem Description
It was reported that during the surgery, the error message of "e3" was displayed on the ultra drive display.The surgeon finished the surgery with a chisel causing significant delay to surgery.No further information is available at the time of this reporting.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device was reported in error.The initial report should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device was reported in error.The initial report should be voided.

• Brand Name: ULTRA-DRIVE III CONSOLE
• Common Device Name: DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9141178
• Report Number: 0001825034-2019-04313
• Device Sequence Number: 3046330
• Product Code: JXE
• UDI-Device Identifier: 00880304467293
• UDI-Public: 00880304467293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 423935
• Device Lot Number: 25177
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention