FDA Adverse Event
Malfunction
Summary report: N
ADJ PIN COLLET 2.0-3.2MM
MDR report key: 1813043
·
Received August 12, 2010
Report
- Report Number
- 1811755-2010-00922
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Date of Event
- July 12, 2010
- Report Date
- July 15, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND IT WAS DETERMINED THAT THE ROOT CAUSE OF THE PIN STICKING IS DUE TO THE WEAR AND FLAKING OF THE IMPREGLON COATING. THIS COATING IS USED INSIDE OF THE COLLET TO PREVENT THE PIN FROM STICKING. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION FROM THE INVESTIGATION IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT COLLET WOULD NOT HOLD THE 2.8 K WIRE. THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADJ PIN COLLET 2.0-3.2MM | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |