FDA Adverse Event
Malfunction
Summary report: N
PADDLE, TROCAR, RECON MODE T2 RECON
MDR report key: 2625699
·
Received June 14, 2012
Report
- Report Number
- 9610622-2012-00264
- Event Type
- Malfunction
- Date Received
- June 14, 2012
- Date of Event
- May 22, 2012
- Report Date
- May 31, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS ¿ KIEL
- Product Code
- HSZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATE DEVICE: (B)(4), ELASTOSIL T-HANDLE LARGE AO COUPLING LOT# K16440.
Description of Event or Problem · 1
IT WAS REPORTED, THE HANDLE AND THE "UPGRADE PADDLE" COULD NOT BE SEPARATED UPON RETURN TO THE BRANCH. THE SURGERY WAS NOT AFFECTED BY THESE ITEMS BEING STUCK TOGETHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PADDLE, TROCAR, RECON MODE T2 RECON | INSTRUMENT | HSZ | STRYKER OSTEOSYNTHESIS ¿ KIEL | NA | K813612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |