FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3970285
·
Received July 31, 2014
Report
- Report Number
- 0002249697-2014-02932
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- June 18, 2014
- Report Date
- July 10, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN DRILL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.
Additional Manufacturer Narrative · 1
PLEASE NOTE THAT THIS EVENT IS DUPLICATE OF STRYKER REPORT (B)(4). A MED WATCH REPORT FOR THE MALFUNCTION HAS BEEN SUBMITTED UNDER MFR REPORT # 0002249697-2014-02932. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UNDER MFR REPORT # 0002249697-2014-02848. THEREFORE, MFR REPORT # 0002249697-2014-02932 IS CONSIDERED CLOSED.
Description of Event or Problem · 1
IT WAS NOTED THAT THE OPEN DRILL GUIDE FOR PERIPHERAL LOCKING SCREWS CAUSED METAL DEBRIS.
Description of Event or Problem · 1
IT WAS NOTED THAT THE OPEN DRILL GUIDE FOR PERIPHERAL LOCKING SCREWS CAUSED METAL DEBRIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447255 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | INSTRUMENT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |