FDA Adverse Event
Malfunction
Summary report: N
LAG SCREWDRIVER 380X110MM
MDR report key: 2072759
·
Received March 31, 2011
Report
- Report Number
- 9610622-2011-00149
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 18, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE SURGEON WAS CARRYING OUT A GAMMA NAILING PROCEDURE, THE TIP OF THE PRODUCT BENT. CUSTOMER REPORTED THAT IT MIGHT JUST BE DUE TO WEAR AND TEAR AS IT IS A CONSIGNED PRODUCT THAT THEY HAVE HAD FOR ABOUT 3 YEARS. NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAG SCREWDRIVER 380X110MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K625128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |