FDA Adverse Event
Malfunction
Summary report: N
WIRE COLLET
MDR report key: 1970396
·
Received January 18, 2011
Report
- Report Number
- 1811755-2011-00169
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 9, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THE DESCRIBED EVENT WAS CAUSED BY METAL FLAKES FALLING INTO THE LARGE COLLET, PREVENTING THE COLLET FROM CLOSING AROUND THE PIN. THE METAL FLAKES WERE CAUSED BY THE SHIM WASHERS LOCATED AROUND THE DRIVESHAFT. WHEN THE SHIM WASHERS WEAR DOWN ON THE DRIVESHAFT, METAL FLAKES ARE PRODUCED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT GRAB A WIRE DURING ROUTINE TESTING. THERE WAS NO PATIENT 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 | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO | 03008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |