FDA Adverse Event
Malfunction
Summary report: N
ADJ PIN COLLET 2.0-3.2MM
MDR report key: 2082063
·
Received April 26, 2011
Report
- Report Number
- 1811755-2011-01400
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 30, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE QUALITY INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SUBSTANCE THAT APPEARED TO BE BLOOD HAD EMERGED FROM BETWEEN THE COLLAR AND THE SPINNING DISTAL TIP SECTION OF THE DEVICE DURING PREPARATION FOR USE. 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 | ADJ PIN COLLET 2.0-3.2MM | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |