Brand Name | ELITE PREMIUM KNOT MANIPULATOR |
Type of Device | ACCESSORIES,ARTHROSCOPIC |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
mansfield MA 02048 |
|
Manufacturer (Section G) |
SMITH & NEPHEW, INC. |
130 forbes boulevard |
|
mansfield MA 02048 |
|
Manufacturer Contact |
jim
gonzales
|
7000 west william cannon drive |
austin, TX 78735
|
|
MDR Report Key | 7642100 |
MDR Text Key | 112597532 |
Report Number | 1219602-2018-00831 |
Device Sequence Number | 1 |
Product Code |
NBH
|
UDI-Device Identifier | 03596010591272 |
UDI-Public | (01)03596010591272(10)50688160 |
Combination Product (y/n) | N |
Reporter Country Code | SW |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
10/10/2018 |
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 | 72201213 |
Device Catalogue Number | 72201213 |
Device Lot Number | 50688160 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/17/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/14/2018
|
Initial Date FDA Received | 06/27/2018 |
Supplement Dates Manufacturer Received | 07/31/2018 10/09/2018
|
Supplement Dates FDA Received | 08/01/2018 10/10/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
Reuse
|
Patient Sequence Number | 1 |