Brand Name | ACL TIGHTROPE WITH FIBERTAG, ABS |
Type of Device | PIN, FIXATION, SMOOTH |
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 | 15743313 |
MDR Text Key | 303181244 |
Report Number | 1220246-2022-05705 |
Device Sequence Number | 1 |
Product Code |
HTY
|
UDI-Device Identifier | 00888867308466 |
UDI-Public | 00888867308466 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K110123 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,User Facility |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
11/07/2022 |
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 | ACL TIGHTROPE WITH FIBERTAG, ABS |
Device Catalogue Number | AR-1588TNT |
Device Lot Number | 14924726 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
10/18/2022
|
Initial Date FDA Received | 11/07/2022 |
Date Device Manufactured | 02/10/2022 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|