Brand Name | AWL-DILATOR, TWINFIX ULTRA, 4.5MM |
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
|
150 minuteman road |
andover, MA 01810
|
5123585706
|
|
MDR Report Key | 5960938 |
MDR Text Key | 55380643 |
Report Number | 1219602-2016-00689 |
Device Sequence Number | 1 |
Product Code |
NBH
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
03/01/2016 |
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 Catalogue Number | 72202633 |
Device Lot Number | 50496350 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/22/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/01/2016
|
Initial Date FDA Received | 09/19/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/11/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |