FDA Adverse Event
Malfunction
Summary report: N
RIGHT-NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP H
MDR report key: 2170804
·
Received June 22, 2011
Report
- Report Number
- 2249697-2011-00939
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 27, 2011
- Report Date
- June 1, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN THE INVESTIGATION IS COMPLETED, THE RESULTS WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT "THE BROACHES FOR THE ABG STEM WIGGLED A BIT ON THE HANDLE WHEN THEY WERE SECURED, THERE WAS A LITTLE PLAY. HAD A BACKUP BROACH WHICH THEY USED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGHT-NAV COMPATIBLE DUAL-OFFSET ACCOLADE RASP H | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | P4T58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |