ERISMA-LP MIS
Received Sep 13, 2023 · Event occurred Jul 18, 2023
Report 3009962553-2023-00002 · MDR key 17739279
Device
Generic name
Erisma Driver Shaft
Manufacturer
Clariance SasModel number
13911009Catalog number
13911009
Lot number
H632X
Product problems
- Fracture
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. IT WAS NOT LOCATED. IT IS UNSURE WHEN THE BREAKAGE OCCURRED: PRIOR TO OR DURING SURGERY. AS A CONSEQUENCE, CLARIANCE WILL FILE AN MDR, OUT OF AN ABUNDANCE OF CAUTION, TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803.
Description of Event or Problem
DRIVERS DISTAL END IS SHEARED OFF. IT IS UNKNOWN IF THIS OCCURRED PRIOR TO OR DURING SURGERY. THE TIP WAS NOT FOUND IN THE SURGICAL SITE OR ON X-RAYS. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO THE SURGERY.
Additional Manufacturer Narrative
IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAD BROKEN OFF. IT WAS NOT LOCATED. IT IS UNSURE WHEN THE BREAKAGE OCCURRED: PRIOR TO OR DURING SURGERY. AS A CONSEQUENCE, CLARIANCE WILL FILE AN MDR, OUT OF AN ABUNDANCE OF CAUTION, TO ENSURE FULL COMPLIANCE WITH 21CFR PART 803. SUPPLEMENTAL REPORT ON 11/29/2023, NOW INCLUDED WITH THIS FILING IS THE ANALYSIS REPORT FROM CLARIANCE SAS.
Description of Event or Problem
DRIVERS DISTAL END IS SHEARED OFF. IT IS UNKNOWN IF THIS OCCURRED PRIOR TO OR DURING SURGERY. THE TIP WAS NOT FOUND IN THE SURGICAL SITE OR ON X-RAYS. THERE WAS NO HARM TO THE PATIENT AND NO DELAY TO THE SURGERY.
Remedial action
- Replace