FDA Adverse Event
Malfunction
Summary report: N
PIN COLLET
MDR report key: 2140396
·
Received June 17, 2011
Report
- Report Number
- 1811755-2011-02213
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 26, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. IF THE DEVICE IS RECEIVED, A QUALITY INVESTIGATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPRING FELL OUT OF THE DEVICE DURING CLEANING. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIN COLLET | GET | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |