FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE T2 GTN
MDR report key: 2823905
·
Received October 10, 2012
Report
- Report Number
- 9610622-2012-00449
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 19, 2012
- Report Date
- September 19, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER SURGERY WAS COMPLETED (T2 GTN CASE), WHILE THE SCRUB TECH WAS DISASSEMBLING THE INSTRUMENT (GTN TARGETER), THE STRIKE PLATE FELL OFF AND LEFT THE THREADS THREADED INTO THE TARGETER. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT AND SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE T2 GTN | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KME903991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |