FDA Adverse Event
Malfunction
Summary report: N
ACCOLADE OFFSET RASP HANDLE
MDR report key: 2050553
·
Received March 15, 2011
Report
- Report Number
- 2249697-2011-00317
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 18, 2011
- Report Date
- February 22, 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
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. OTHER DEVICE WAS REPORTED, LOT # PXE22, MFR DATE 09/13/2003.
Description of Event or Problem · 1
TWO EXETER RASP HANDLES BROKEN. ANOTHER IDENTICAL DEVICE IMMEDIATELY AVAILABLE AND COMPLETED SURGERY AS ORIGINALLY PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCOLADE OFFSET RASP HANDLE | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | P5E93 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |