FDA Adverse Event
Malfunction
Summary report: N
PIN COLLET
MDR report key: 2241601
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03251
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 10, 2011
- Report Date
- August 10, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE IMPREGLON COATING ON THE DEVICE WAS WORN OFF. THIS CONDITION COULD CAUSE THE DEVICE TO STICK, AND NOT ALLOW THE COLLET TO RELEASE THE WIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE WIRE WAS STUCK IN THE DEVICE. NO FURTHER INFO REGARDING PT INVOLVEMENT OR ADVERSE CONSEQUENCES HAS BEEN RECEIVED FROM THE ACCOUNT, DESPITE NUMEROUS ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIN COLLET | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |