FDA Adverse Event
Malfunction
Summary report: N
RESTORE FEMORAL AIMER, 7MM OFFSET
MDR report key: 1001869
·
Received February 25, 2008
Report
- Report Number
- 1221934-2008-00087
- Event Type
- Malfunction
- Date Received
- February 25, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 14, 2008
- Manufacturer
- DEPUY MITEK
- Product Code
- NBH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN THE COMPLAINT DEVICE IS RECEIVED, IT WILL BE EVALUATED, AND IF A ROOT CAUSE CAN BE ESTABLISHED, IT WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.
Description of Event or Problem · 1
OUR REP IS REPORTING THAT DURING AN ARTHROSCOPIC KNEE REPAIR, METAL FILINGS EMANATING FROM A BEATH PIN AND A RESTORE FEMORAL AIMER WERE OBSERVED FALLING INTO THE PATIENT'S JOINT SPACE. UPON FURTHER EXAMINATION, IT WAS NOTED THAT THE "FEMORAL AIMER" WAS BENT, THIS CONDITION WAS THE PRECIPITATOR OF THE METAL FILINGS. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE FEMORAL AIMER, 7MM OFFSET | ARTHROSCOPIC INSTRUMENT | NBH | DEPUY MITEK | 219357 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |