FDA Adverse Event
Malfunction
Summary report: N
PIN COLLET
MDR report key: 2090242
·
Received April 19, 2011
Report
- Report Number
- 1811755-2011-01319
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 22, 2011
- Report Date
- March 23, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE WAS CORROSION ON ALL INTERNAL COMPONENTS. THIS INNER CORROSION WILL CAUSE THE DEVICE TO NOT FULLY GRIP OR RETAIN THE PIN. THE CORROSION WAS LIKELY CAUSED BY IMPROPER CLEANING AND STERILIZATION OF PRODUCT AND THE AGE OF THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN DURING ROUTINE MAINTENANCE. THERE WAS NO DELAY 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 |