FDA Adverse Event
Malfunction
Summary report: N
CLEAR CANNULA, 5.5MM X 90MM
MDR report key: 2060815
·
Received March 11, 2011
Report
- Report Number
- 1221934-2011-00102
- Event Type
- Malfunction
- Date Received
- March 11, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 2, 2011
- Manufacturer
- DEPUY MITEK
- Product Code
- GEA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A F/U REPORT.
Description of Event or Problem · 1
OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC PROCEDURE, A PORTION OR ALL OF THE DAM SECTION OF 2 CANNULAS BROKE AWAY INTO THE PT'S JOINT SPACE. THE FRAGMENTS WERE EASILY RETRIEVED AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. THE COMPLAINT DEVICES WERE DISCARDED AT USER FACILITY. ALSO SEE ASSOCIATED MDR 1221934-2011-00103.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEAR CANNULA, 5.5MM X 90MM | ARTHROSCOPIC INSTRUMENT | GEA | DEPUY MITEK | 214110 | 093079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |