FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE GAMMA3 300X160MM
MDR report key: 2885323
·
Received November 20, 2012
Report
- Report Number
- 9610622-2012-00538
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Date of Event
- November 12, 2012
- Report Date
- November 13, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: (B)(4) SPEEDLOCK SLEEVE GAMMA3 180 LOT # KP297229; (B)(4) SPEEDLOCK SLEEVE GAMMA3 200 LOT # KP285091.
Description of Event or Problem · 1
AN EMPLOYEE FROM OUR CUSTOMER REPORTED TO OUR SALES REP THAT HE WAS OBSERVING A SURGERY PROCEDURE. DURING THIS HE OBSERVED THAT FAULTY DRILLING HAPPENED DURING THE PROCEDURE. NO DELAY AND THE SURGERY WAS SUCCESSFULLY COMPLETED AT THE END.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE GAMMA3 300X160MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | KME902550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |