FDA Adverse Event
Malfunction
Summary report: N
MIS DISTAL RESECTION GUIDE LT
MDR report key: 1865079
·
Received October 5, 2010
Report
- Report Number
- 2249697-2010-01313
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- September 13, 2010
- Report Date
- September 15, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "THE 6541-5-721 WAS NOTED BY SURGEON TO HAVE A DRILL HOLE IN THE +0 POSITION THAT WOULD NOT ALLOW SAFE PASSAGE OF DRILL BIT TO FIXATE THE BLOCK TO PT BONE. THE DR. SUBSEQUENTLY PLANNED IN THE +2 DRILL HOLE WITHOUT ISSUE AND SAFELY PERFORMED PROCEDURE WITHOUT INCIDENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIS DISTAL RESECTION GUIDE LT | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | AF1A02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other |