FDA Adverse Event
Malfunction
Summary report: N
WIRE COLLET
MDR report key: 2241592
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03255
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 24, 2011
- Report Date
- August 24, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HRX
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE WAS DEBRIS BUILT UP INSIDE THE DEVICE. THE CONDITION COULD CAUSE THE DEVICE TO NOT RETAIN THE PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT RETAIN A PIN DURING TESTING AT THE MFR. THERE WAS NO PT 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 | GET | HRX | STRYKER INSTRUMENTS KALAMAZOO | 08210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |