FDA Adverse Event
Malfunction
Summary report: N
MINIATURE PIN AND LIGATURE CUTTER
MDR report key: 1882644
·
Received October 22, 2010
Report
- Report Number
- 2086211-2010-00121
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Report Date
- September 24, 2010
- Manufacturer
- GAC INTERNATIONAL
- Product Code
- EJB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST 2 YEARS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT.
Description of Event or Problem · 1
IN THIS EVENT IT WAS REPORTED THAT THE TIP OF A MINIATURE PIN AND LIGATURE CUTTER SEPARATED; THERE IS NO INDICATION THAT INJURY RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MINIATURE PIN AND LIGATURE CUTTER | EJB | GAC INTERNATIONAL | 09-36 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 012 NITI| 010 NITI |