Brand Name | 1.6MM KIRSCHNER WIRE WITH 5MM THREAD- TROCAR POINT 150MM |
Type of Device | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Manufacturer (Section D) |
SYNTHES USA |
1302 wrights lane e |
west chester PA 19380 |
|
MDR Report Key | 14944531 |
MDR Text Key | 295415448 |
Report Number | 14944531 |
Device Sequence Number | 1 |
Product Code |
KTT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/05/2022,06/28/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 292.71 |
Device Catalogue Number | 29271 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 07/05/2022 |
Date Report to Manufacturer | 07/07/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 07/07/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 24820 DA |
Patient Sex | Male |
Patient Weight | 75 KG |
Patient Race | White |
|
|