FDA Adverse Event
Malfunction
Summary report: N
NAIL HOLDING SCREW, TIBIA 10 MM
MDR report key: 2090625
·
Received April 19, 2011
Report
- Report Number
- 9610622-2011-00169
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 30, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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.
Description of Event or Problem · 1
IT WAS REPORTED VIA OUR SALES REP, THAT DURING THE ASSEMBLY OF THE S2 TIBIA NAIL ON THE TARGETING DEVICE, THE CONNECTION SCREW COMPLETELY BLOCKED IN THE NAIL, MAKING IT IMPOSSIBLE TO TIGHTEN IT COMPLETELY OR TO REMOVE IT FROM THE NAIL. SHE FURTHER REPORTS THAT A SECOND INSTRUMENT WAS AVAILABLE TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAIL HOLDING SCREW, TIBIA 10 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |