Brand Name | ACL TIGHTROPE WITH FIBERTAG, ABS |
Type of Device | SMOOTH FIXATION PIN |
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 | 18654718 |
MDR Text Key | 334701264 |
Report Number | 1220246-2024-00811 |
Device Sequence Number | 1 |
Product Code |
HTY
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K110123 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
02/06/2024 |
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 | 15013100 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/18/2024 |
Initial Date FDA Received | 02/06/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/18/2022 |
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 |
|
|