FDA Adverse Event
Malfunction
Summary report: N
FEMORAL IMPACTOR EXTRACTOR
MDR report key: 2182136
·
Received June 23, 2011
Report
- Report Number
- 2249697-2011-00943
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 3, 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
- AS
- 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. ADDITIONAL INFO WAS REQUESTED. IF DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
LOAN TRIATHLON SET USED AT (B)(6) HOSPITAL ON (B)(6) 2011 BY DR (B)(6). FEMORAL IMPACTOR/EXTRACTOR (6541-4-807) SEIZED MID CASE AND COULD NOT BE USED TO INSERT FINAL COMPONENT. WAITED 30MINS TO GET ONE FROM ANOTHER HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FEMORAL IMPACTOR EXTRACTOR | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |