FDA Adverse Event
Malfunction
Summary report: N
DISTAL TARGETING DEVICE R1.5
MDR report key: 2272170
·
Received August 26, 2011
Report
- Report Number
- 9610622-2011-00404
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 4, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- 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
ASSOCIATED DEVICE: FIXATION BOLT 9X50 MM, CATALOG # 1320-5330, LOT # K295009. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
DURING SURGERY, WHEN THE SURGEON WAS ABOUT TO ASSEMBLE THE DISTAL TARGETING DEVICE TO G3 TARGET ARM, IT WAS NOT POSSIBLE TO ASSEMBLE IT. THE FIXATION BOLT WAS NOT ABLE TO BE INSERTED. THEREFORE THE SURGEON USED THE RADIOLUCENT DRILL TO DO DISTAL SCREW HOLE DRILLING. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISTAL TARGETING DEVICE R1.5 | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KP308616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |