FDA Adverse Event
Malfunction
Summary report: N
ADJ WIRE COLLET 0.7-1.8MM
MDR report key: 2955700
·
Received February 11, 2013
Report
- Report Number
- 0001811755-2013-00241
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 30, 2013
- Report Date
- January 30, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS NOTED DURING FAILURE ANALYSIS THAT WEAR ON THE DRIVESHAFT MAY PRODUCE METAL SHAVINGS. THEREFORE, IT IS LIKELY THE REPORTED EVENT WAS DUE TO DRIVESHAFT SCORING.
Description of Event or Problem · 1
THE ADJ WIRE COLLET 0.7-1.8MM WAS SENT FOR SERVICE AND DURING FAILURE ANALYSIS IT WAS NOTED THAT THERE ARE METAL SHAVINGS BY THE DRIVESHAFT AND LEVER OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59392 | ADJ WIRE COLLET 0.7-1.8MM | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT | KIJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |