FDA Adverse Event
Malfunction
Summary report: N
2.0MM CANNULATED DRILL BIT, 150MM
MDR report key: 3595304
·
Received January 28, 2014
Report
- Report Number
- 2520274-2014-00087
- Event Type
- Malfunction
- Date Received
- January 28, 2014
- Date of Event
- December 26, 2013
- Report Date
- January 2, 2014
- Manufacturer
- SYNTHES USA
- Product Code
- HWE
- PMA / PMN Number
- K951304
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.ADDITIONAL PRODUCT CODES: HSZ, GFA, AND GFF.INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.PLACEHOLDER
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BITS JUST SUDDENLY BREAK WHILE DRILLING IT INTO THE NAVICULAR BONE. THE PATIENT IS STABLE AND NO HARM HAPPENED. IT ONLY TOOK 5 MINUTES FOR THE DURATION IN REMOVING THE BROKEN PIECES. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61542 | 2.0MM CANNULATED DRILL BIT, 150MM | HWE | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |