FDA Adverse Event
Malfunction
Summary report: N
ADJ PIN COLLET 2.0-3.2MM
MDR report key: 2160679
·
Received June 30, 2011
Report
- Report Number
- 1811755-2011-02309
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 11, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF. THIS CONDITION COULD CAUSE THE DEVICE TO NOT RETAIN THE PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN. IT IS UNK IF THERE WAS ANY PT INVOLVEMENT OR ANY ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE FROM THE ACCOUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADJ PIN COLLET 2.0-3.2MM | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |