ULTRA-DRIVE III HANDPIECE
Received Aug 24, 2018 · Event occurred Jul 26, 2018
Report 0001825034-2018-08520 · MDR key 7812446
Device
Generic name
Device, Nerve Conduction Velocity Measurement
Manufacturer
Zimmer Biomet, Inc.Model number
N/ACatalog number
423936
Lot number
42396
Product problems
- Noise, Audible
- Unexpected Shutdown
- Noise, Audible
- Unexpected Shutdown
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). FOREIGN COUNTRY: (B)(6). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08518, 0001825034 - 2018 - 08521
Description of Event or Problem
IT WAS REPORTED THAT, DURING SURGERY, THE DEVICE MADE A STRANGE NOISE AND ERROR MESSAGES WERE DISPLAYED ON THE FRONT PANEL OF THE DEVICE AND ULTIMATELY THE DEVICE STOPPED WORKING, CAUSING A DELAY TO THE PROCEDURE OVER THIRTY (30) MINUTES. SURGERY WAS COMPLETED WITH MANUAL INSTRUMENTATION SUCCESSFULLY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PRODUCT WAS NOT RETURNED FOR EVALUATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. SUPPLIER DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.