FDA Adverse Event
Malfunction
Summary report: N
ADJ PIN COLLET 2.0 - 3.2 MM
MDR report key: 2710963
·
Received August 15, 2012
Report
- Report Number
- 1811755-2012-03149
- Event Type
- Malfunction
- Date Received
- August 15, 2012
- Date of Event
- July 19, 2012
- Report Date
- July 19, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE USER FACILITY, IT IS NOT REPAIRABLE ONCE IT IS DISASSEMBLED.
Description of Event or Problem · 1
AN ADJ PIN COLLET 2.0-3.2MM WAS SENT FOR EVAL AND METAL SHAVINGS WERE COMING OUT OF THE DEVICE DURING PERFORMANCE TESTING. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADJ PIN COLLET 2.0 - 3.2 MM | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |