Brand Name | SHAVER HP, SYNERGY, HANDCONTROL |
Type of Device | POWERED SURG ORTHOPEDIC INSTR |
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 | 17419021 |
MDR Text Key | 320126378 |
Report Number | 1220246-2023-07359 |
Device Sequence Number | 1 |
Product Code |
HWE
|
UDI-Device Identifier | 00888867123991 |
UDI-Public | 00888867123991 |
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Administrator/Supervisor
|
Type of Report
| Initial |
Report Date |
07/28/2023 |
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 | SHAVER HP, SYNERGY, HANDCONTROL |
Device Catalogue Number | AR-8332H |
Device Lot Number | 10161392 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
06/12/2023
|
Initial Date FDA Received | 07/28/2023 |
Date Device Manufactured | 09/28/2017 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|