FDA Adverse Event
Malfunction
Summary report: N
CANNULATED REAMER FOR AIMER SYSTEM
MDR report key: 2210753
·
Received August 12, 2011
Report
- Report Number
- 1825034-2011-00708
- Event Type
- Malfunction
- Date Received
- August 12, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 16, 2011
- Manufacturer
- BIOMET SPORTS MEDICINE
- Product Code
- HTO
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PROBLEM WAS NOT DESIGN OR PRODUCT RELATED. CLEANING AND STERILIZATION FROM PREVIOUS SURGERY CAUSED AND CONTRIBUTED TO REPORTED EVENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2011, SURGEON WAS ATTEMPTING TO PASS A CANNULATED REAMER OVER THE GUIDE PIN. SURGEON NOTED THAT THERE WAS BONE FROM A PREVIOUS PROCEDURE LODGED IN THE REAMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULATED REAMER FOR AIMER SYSTEM | REAMER | HTO | BIOMET SPORTS MEDICINE | N/A | 124409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |