FDA Adverse Event
Malfunction
Summary report: N
ELASTOSIL T-HANDLE LARGE AO COUPLING
MDR report key: 2100175
·
Received May 13, 2011
Report
- Report Number
- 9610622-2011-00216
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- April 28, 2011
- Report Date
- April 28, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE NURSE AT THE HOSPITAL, REPORTED TO OUR CUSTOMER CARE, WHILE OBSERVING A SURGERY, IT WAS NOTICED AFTER THE SURGERY WAS COMPLETED THE T-HANDLE AND THE REAMER COULDN'T BE DISASSEMBLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELASTOSIL T-HANDLE LARGE AO COUPLING | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |