2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE

Additional Manufacturer Narrative

(B)(4). 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: 0001032347-2019-00021 THROUGH 0001032347-2019-00024.

Description of Event or Problem

IT WAS REPORTED THE DEPTH GAGE WAS BROKEN. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

Description of Event or Problem

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE PRODUCT IDENTITIES WERE CONFIRMED. THE 2.0 MM/ 2.4 MM SYSTEM 45 MM, LONG, DEPTH GAGE (PART# 01-9125, LOT #: 612980, SERIAL# 413328) WAS VISUALLY EVALUATED. THE GAGE SHOWED SIGNS OF USE WITH SOME SCRATCHES AT THE BASE OF THE HANDLE AND A BENT GAGE GUIDE. THE DEPTH GAGE CANNOT PROVIDE AN ACCURATE DEPTH MEASUREMENT WITH A BENT GUIDE, THEREFORE THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS EXCESSIVE FORCE WAS APPLIED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IN THE WARNINGS AND PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT IT IS STATED, 'AVOID UNDUE STRESS OR STRAIN WHEN HANDLING OR CLEANING INSTRUMENTS.' THE DISCOLORATION IS MOST LIKELY DUE TO RESIDUAL FROM THE CLEANING PROCESS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2019-00022-1, 0001032347-2019-00022-1, 0001032347-2019-00024-1, AND AND 0001032347-2019-00067.