ERISMA-LP MIS
Received Mar 10, 2021 · Event occurred Feb 4, 2021
Report 3009962553-2021-00001 · MDR key 11453367
Device
Generic name
Screwdriver Shaft
Manufacturer
Clariance SasModel number
13911009Catalog number
13911009
Lot number
JA01N
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
AFTER STERILIZATION HAD BEEN COMPLETED AND THE INSTRUMENTS WERE BEING PUT BACK INTO THE TRAYS IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. THE TIP WAS NOT LOCATED, AND IT IS UNSURE WHEN THE BREAKAGE OCCURRED.
Additional Manufacturer Narrative
INITIAL REPORT - 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. SUPPLEMENTAL REPORT - AS THIS ISSUE WAS NOTICED POST-SURGERY-STERILIZATION, IT IS UNSURE AS TO WHEN THE SCREWDRIVER TIP BROKE. 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, WHICH CONCLUDED THAT THE TWO MAIN CAUSES OF SCREWDRIVER SHAFT BREAKAGE ARE DUE TO A BENDING STRESS APPLIED TO THE INSTRUMENT DURING SURGERY, AND TORSION STRESS APPLIED TO THE INSTRUMENT BY THE SURGEON SURING SURGERY.
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.
Description of Event or Problem
AFTER STERILIZATION HAD BEEN COMPLETED AND THE INSTRUMENTS WERE BEING PUT BACK INTO THE TRAYS IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. THE TIP WAS NOT LOCATED, AND IT IS UNSURE WHEN THE BREAKAGE OCCURRED.
Remedial action
- Replace