FDA Adverse Event
Malfunction
Summary report: N
WIRE COLLET
MDR report key: 2082602
·
Received April 27, 2011
Report
- Report Number
- 1811755-2011-01460
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 2, 2011
- Report Date
- April 6, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- 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, THERE WAS CORROSION AND DEBRIS BUILT UP INSIDE THE DEVICE. THIS CONDITION COULD CAUSE THE DEVICE TO NOT RETAIN THE PIN. THE MOST LIKELY CAUSE OF THE DEBRIS AND CORROSION IS IMPROPER CLEANING AND STERILIZATION.
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 CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WIRE COLLET | GET | STRYKER INSTRUMENTS KALAMAZOO | 09098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |