FDA Adverse Event
Malfunction
Summary report: N
ADJ PIN COLLET 2.0-3.2MM
MDR report key: 1791636
·
Received July 29, 2010
Report
- Report Number
- 1811755-2010-00848
- Event Type
- Malfunction
- Date Received
- July 29, 2010
- Date of Event
- July 2, 2010
- Report Date
- July 6, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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 ADD'L INFO FROM THE INVESTIGATION IS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PINS WOULD NOT FIT OR HOLD IN THE PIN COLLET. THIS OCCURRED DURING A PROCEDURE WHICH CAUSED A DELAY OF 10 MINUTES SO A BACK UP DEVICE COULD BE OBTAINED. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED DUE TO THIS EVENT; THERE WAS NO ADVERSE CONSEQUENCE DUE TO THIS EVENT.
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 |