FDA Adverse Event
Malfunction
Summary report: N
ADJUSTABLE WIRE COLLET
MDR report key: 3013100
·
Received March 20, 2013
Report
- Report Number
- 0001811755-2013-00555
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 1, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MP, IN
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE DEVICE IS RECEIVED AND EVALUATED.
Additional Manufacturer Narrative · 1
DURING THE DEVICE EVALUATION, DAMAGED BEARINGS WERE FOUND BY THE TECHNICIAN AT THE SERVICE CENTER IN INDIA. THE PRESENCE OF DAMAGED BEARINGS ARE LIKELY TO CAUSE OR CONTRIBUTE TO THE REPORTED EVENT OF OVERHEATING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ADJUSTABLE WIRE COLLET WAS GETTING HOT DURING TESTING AND INSPECTION. THERE WAS NO PATIENT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ADJUSTABLE WIRE COLLET WAS GETTING HOT DURING TESTING AND INSPECTION. THERE WAS NO PATIENT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116427 | ADJUSTABLE WIRE COLLET | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | KIJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |