Brand Name | KNEE SCORPION |
Type of Device | MANUAL INSTR, GENERAL SURGICAL |
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 | 19162629 |
MDR Text Key | 341394728 |
Report Number | 1220246-2024-02230 |
Device Sequence Number | 1 |
Product Code |
NBH
|
UDI-Device Identifier | 00888867196322 |
UDI-Public | 00888867196322 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/23/2024 |
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 | KNEE SCORPION |
Device Catalogue Number | AR-12990 |
Device Lot Number | 78221 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/18/2021 |
Initial Date Manufacturer Received |
03/29/2021
|
Initial Date FDA Received | 04/23/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/18/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |