FDA Adverse Event
Malfunction
Summary report: N
NAIL HOLDING SCREW 8X35MM
MDR report key: 1888238
·
Received October 28, 2010
Report
- Report Number
- 9610622-2010-00465
- Event Type
- Malfunction
- Date Received
- October 28, 2010
- Date of Event
- October 7, 2010
- Report Date
- October 13, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE ASSOCIATED DEVICE IN THIS EVENT IS (B)(4) TARGET DEVICE LOT NO. K1250871.
Description of Event or Problem · 1
IT WAS REPORTED BY THE HEAD OF THEATRE, VIA SALES REP THAT THE SCREW COULD NOT BE SCREWED IN OR RATHER IT WAS VERY HARD TO SCREW IN. THE SURGEON HAD NO PROBLEM WHILE OPERATING. HE FURTHER REPORTED THAT THE SURGEON FAILED THE HOLE IN SPITE OF USING A TARGET DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAIL HOLDING SCREW 8X35MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K715331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |