FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN RIGIDFIX FEMORAL ROD
MDR report key: 1022488
·
Received March 31, 2008
Report
- Report Number
- 1221934-2008-00160
- Event Type
- Malfunction
- Date Received
- March 31, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 20, 2008
- Manufacturer
- DEPUY MITEK
- Product Code
- HRX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MITEK IS AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A ROOT CAUSE FAILURE ANALYSIS. THE RESULTS OF OUR EVALUATION WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR REP REPORTS THAT DURING A KNEE REPAIR, THE SURGEON OBSERVED METAL FILINGS EMANATING FROM THE FEMORAL ROD FALLING INTO THE BONE TUNNEL. ALL WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN RIGIDFIX FEMORAL ROD | ARTHROSCOPIC INSTRUMENT | HRX | DEPUY MITEK | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |