FDA Adverse Event
Malfunction
Summary report: N
DRILL BIT, LG (HAND)
MDR report key: 1738377
·
Received June 22, 2010
Report
- Report Number
- 2249697-2010-00712
- Event Type
- Malfunction
- Date Received
- June 22, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 1, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- EJL
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT "DR WAS DRILLING USING THIS DRILL BIT THROUGH THE CORRESPONDING DRILL GUIDE, BIT FRACTURED AT THE BASE TOWARDS THE THREADS. NO PIECE IN PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DRILL BIT, LG (HAND) | INSTRUMENT | EJL | STRYKER ORTHOPAEDICS MAHWAH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |