FDA Adverse Event
Malfunction
Summary report: N
HUDSON/MODIFIED TRINKLE ATTACH
MDR report key: 1894677
·
Received November 5, 2010
Report
- Report Number
- 1811755-2010-01608
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 8, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AS OF THE DATE OF THIS REPORT. THIS REPORT WILL BE UPDATED WHEN THE DEVICE IS RETURNED AND THE EVAL IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE TOP OF THE STERILIZATION CASE WAS REMOVED THERE WAS A RING OF LUBRICANT ON THE BOTTOM OF THE CASE. THE CASE WAS REMOVED AND REPLACEMENT DEVICES WERE BROUGHT IN TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON/MODIFIED TRINKLE ATTACH | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |