FDA Adverse Event
Other
Summary report: N
QUICK RELEASE DRILL
MDR report key: 507446
·
Received January 15, 2004
Report
- Report Number
- 1825034-2004-00002
- Event Type
- Other
- Date Received
- January 15, 2004
- Date of Event
- December 12, 2003
- Report Date
- December 23, 2003
- Manufacturer
- BIOMET, INC.
- Product Code
- HTW
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT PT UNDERWENT TOTAL KNEE ARTHROPLASTY IN 2003. FOLLOWING PROCEDURE, FOLLOW-UP RADIOGRAPH INDICATED RETAINED FOREIGN BODY. PT UNDERWENT PROCEDURE ONE MONTH LATER TO REMOVE RETAINED DRILL BIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUICK RELEASE DRILL | INSTRUMENT, DRILL | HTW | BIOMET, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other |