FDA Adverse Event
Malfunction
Summary report: N
D/M ONE-SIDED CABLE TENSIONER
MDR report key: 2224076
·
Received August 17, 2011
Report
- Report Number
- 2249697-2011-01205
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 26, 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
- JA
- 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 'D-M 2.0MM BEADED CABLE' WAS REEVED TO FEMORAL BONE SHAFT AND TIGHTENED BY 'D/M ONE-SIDED CABLE TENSIONER'. THE CABLE STUCK WHEN THE TENSIONER WAS TIGHTENED A LITTLE. AND, THE TENSIONER COULD NOT BE TIGHTENED OR LOOSENED. SO, THE SURGEON USED A SPARE TENSIONER AND CABLE. THERE IS ABOUT 15 MIN DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | D/M ONE-SIDED CABLE TENSIONER | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | ACC196J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |