FDA Adverse Event
Malfunction
Summary report: N
TEARDROP HANDLE, AO COUPLING CANNULATED
MDR report key: 2112231
·
Received April 29, 2011
Report
- Report Number
- 9610622-2011-00192
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 12, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. SAME PATIENT EVENT AS MDR 9610622-2011-00191.
Description of Event or Problem · 1
HEAD OF THEATRE, INDICATED THAT THE TEARDROP HANDLES WERE USED DURING AN EXTRACTION PROCEDURE AND THAT BOTH ADAPTERS USED ARE JAMMED IN THE TEARDROP HANDLES. HE FURTHER REPORTS THAT THE OPERATION WENT WELL AND ONLY AFTER DECONTAMINATION, A TECHNICIAN FROM THE HOSPITAL SEPARATED ADAPTERS AND TEARDROP HANDLES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEARDROP HANDLE, AO COUPLING CANNULATED | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K915222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |