FDA Adverse Event
Malfunction
Summary report: N
PIN COLLET
MDR report key: 2241606
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03245
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 16, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
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 NOT RETAIN THE PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN DURING ROUTINE MAINTENANCE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCE ASSOCIATED WITH THIS EVENT.
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 |