FDA Adverse Event
Malfunction
Summary report: N
INSTRUMENT TRACKER
MDR report key: 3840671
·
Received May 30, 2014
Report
- Report Number
- 0001811755-2014-01987
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 6, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HAW
- PMA / PMN Number
- K022365
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT YET RETURNED FOR INVESTIGATION.
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED BY THE MANUFACTURER FOLLOWING EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSTRUMENT TRACKER WAS MISSING A SCREW WHERE THE BATTERY ATTACHES DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSTRUMENT TRACKER WAS MISSING A SCREW WHERE THE BATTERY ATTACHES DURING STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318971 | INSTRUMENT TRACKER | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |