FDA Adverse Event
Malfunction
Summary report: N
TARGETING ARM
MDR report key: 2050557
·
Received March 15, 2011
Report
- Report Number
- 9610622-2011-00111
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 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
ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. DEVICES ALSO INVOLVED ARE, NAIL ADAPTER (B)(4), LOT# KHI081605, AND TARGET ARM (B)(4) , LOT# KP226308.
Description of Event or Problem · 1
THE THEATRE NURSE, REPORTS VIA OUR BUSINESS UNIT MANAGER, THAT THERE WERE SOME MISS DRILLING WITH THE T2 RECON TARGET DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGETING ARM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | UNK | KP226308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |