FDA Adverse Event
Malfunction
Summary report: N
PIN COLLET
MDR report key: 2000215
·
Received February 18, 2011
Report
- Report Number
- 1811755-2011-00526
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Date of Event
- January 30, 2011
- Report Date
- January 31, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE WAS DEBRIS BUILT UP INSIDE THE DEVICE. THIS CONDITION COULD CAUSE THE DEVICE TO NOT RETAIN A PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN DURING ROUTINE MAINTENANCE. 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 | PIN COLLET | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHM | HRX | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |