FDA Adverse Event
Injury
Summary report: N
ACCU-LINE QUICK RELEASE DRILL BIT
MDR report key: 1953115
·
Received January 7, 2011
Report
- Report Number
- 1825034-2011-00011
- Event Type
- Injury
- Date Received
- January 7, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 10, 2010
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- HTW
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010. DURING THE PROCEDURE, THE TIP OF THE DRILL BIT FRACTURED AND REMAINS IN THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED WITH NO SIGNIFICANT DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-LINE QUICK RELEASE DRILL BIT | DRILL BIT | HTW | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R| S |