FDA Adverse Event
Malfunction
Summary report: N
D/M ONE-SIDED CABLE TENSIONER
MDR report key: 2843639
·
Received October 25, 2012
Report
- Report Number
- 2249697-2012-02073
- Event Type
- Malfunction
- Date Received
- October 25, 2012
- Date of Event
- September 28, 2012
- Report Date
- October 1, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
THE NURSE OF THE HOSP REPORTED TO OUR SALES REP THAT SHE WAS CLEANING THE INSTRUMENTS. DURING THIS SHE OBSERVED THAT DIRT RUNS OUT FROM THE INSIDE AFTER MULTIPLE CLEANING. ALSO IN THE ULTRASONIC BATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | D/M ONE-SIDED CABLE TENSIONER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | TACL907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |