ERISMA-LP MIS

Description of Event or Problem

UPON RECEIPT INSPECTION OF A SET AFTER A TRANSFER, THE INITIAL REPORTER NOTICED THE TIP WAS BROKEN FROM AN MIS SCREWDRIVER SHAFT IN THE SET. THE TIP WAS NOT LOCATED IN THE SET. THE INSTRUMENT WAS NOT USED IN ANY SURGERIES BY THE INITIAL REPORTER.

Additional Manufacturer Narrative

ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS LIKELY NOT REPORTABLE, THE COMPANY HAS DECIDED TO FILE THIS MDR IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. (B)(6) 2019 - AS THIS ISSUE WAS IDENTIFIED UPON RECEIPT INSPECTION AND THE DEVICE WAS NOT USED DURING A SURGERY, THE COMPANY HAS DECIDED TO FILE AN MDR OUT OF AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS IN A STATE WHICH MADE ANALYSIS IMPOSSIBLE. AS SUCH, NO ANALYSIS WAS ABLE TO BE PERFORMED. HOWEVER, THE MANUFACTURER HAS IDENTIFIED THAT THE TWO MAIN CAUSES OF SCREWDRIVER SHAFT BREAKAGE ARE DUE TO A BENDING STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY, AND TORSION STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON DURING SURGERY.

Description of Event or Problem

UPON RECEIPT INSPECTION OF A SET AFTER A TRANSFER, THE INITIAL REPORTER NOTICED THE TIP WAS BROKEN FROM AN MIS SCREWDRIVER SHAFT IN THE SET. THE TIP WAS NOT LOCATED IN THE SET. THE INSTRUMENT WAS NOT USED IN ANY SURGERIES BY THE INITIAL REPORTER.