FDA Adverse Event
Malfunction
Summary report: N
ACCUPORT
MDR report key: 6966236
·
Received October 20, 2017
Report
- Report Number
- 3008812173-2017-00024
- Event Type
- Malfunction
- Date Received
- October 20, 2017
- Report Date
- December 22, 2017
- Manufacturer
- ZIMMER KNEE CREATIONS, INC.
- Product Code
- FGY
- PMA / PMN Number
- PN/A
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS CURRENTLY IN-PROCESS. A SUPPLEMENTAL FOLLOW UP WILL BE SENT ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
PER THE INVESTIGATION, THE CANNULA WAS MANIPULATED IN THE PATIENT WITHOUT THE STYLUS, RESULTING IN A FRACTURE OF THE INSTRUMENT. NO FRAGMENTS WERE GENERATED. THE STYLUS WAS REINSERTED INTO THE CANNULA AND WAS REMOVED FROM THE BODY IN ONE PIECE. THERE WAS NO ADDITIONAL PATIENT TREATMENT AFTER THE INCIDENT. THE MOST LIKELY ROOT CAUSE IS USER TECHNIQUE.
Description of Event or Problem · 1
CANNULA FRACTURED THROUGH 2ND HOLE.
Description of Event or Problem · 1
CANNULA FRACTURED THROUGH 2ND HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 746485 | ACCUPORT | CANNULA | FGY | ZIMMER KNEE CREATIONS, INC. | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |