ERISMA-LP MIS
Report
- Report Number
- 3009962553-2023-00002
- Event Type
- Malfunction
- Date Received
- September 13, 2023
- Date of Event
- July 18, 2023
- Report Date
- August 8, 2023
- Manufacturer
- CLARIANCE SAS
- Product Code
- LRZ
- UDI-DI
- 03700780627271
- PMA / PMN Number
- K162367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- 003
Narratives
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2061093 | ERISMA-LP MIS | ERISMA DRIVER SHAFT | LRZ | CLARIANCE SAS | 13911009 | H632X | 03700780627271 |
| 327653 | ERISMA-LP MIS | ERISMA DRIVER SHAFT | LRZ | CLARIANCE SAS | 13911009 | H632X | 03700780627271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |