Brand Name | SUTURE ANCHOR, CORKSCREW FT II |
Type of Device | SCREW, FIXATION, BONE |
Manufacturer (Section D) |
ARTHREX, INC. |
1370 creekside boulevard |
naples FL 34108 1945 |
|
Manufacturer (Section G) |
ARTHREX, INC. |
1370 creekside boulevard |
|
naples FL 34108 1945 |
|
Manufacturer Contact |
|
MDR Report Key | 11688572 |
MDR Text Key | 248535655 |
Report Number | 1220246-2021-02912 |
Device Sequence Number | 1 |
Product Code |
HWC
|
UDI-Device Identifier | 00888867023703 |
UDI-Public | 00888867023703 |
Combination Product (y/n) | N |
Reporter Country Code | CI |
PMA/PMN Number | K061863 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
04/19/2021 |
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 | SUTURE ANCHOR, CORKSCREW FT II |
Device Catalogue Number | AR-1928SF-2 |
Device Lot Number | 12129266 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/30/2021 |
Initial Date FDA Received | 04/19/2021 |
Date Device Manufactured | 11/18/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|