FDA Adverse Event
Malfunction
Summary report: N
HIGH TORQUE HUDSON/MODIFIED TRINKLE REAMER
MDR report key: 3100391
·
Received May 8, 2013
Report
- Report Number
- 0001811755-2013-01062
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Date of Event
- April 24, 2013
- Report Date
- April 26, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION, IT WAS CONFIRMED THAT THERE WAS EVIDENCE OF A LEAKED SUBSTANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING CLEANING THE HIGH TORQUE HUDSON/MODIFIED TRINKLE REAMER LEAKED. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO THE USER REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200550 | HIGH TORQUE HUDSON/MODIFIED TRINKLE REAMER | INSTRUMENT, SURGICAL, ORTHOPED | HWE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |