Brand Name | DRILL, 2.6 MM,BIORAPTOR 2.3 SUT ANC |
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 | 5962895 |
MDR Text Key | 55437298 |
Report Number | 1219602-2016-00706 |
Device Sequence Number | 1 |
Product Code |
NBH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
05/24/2013 |
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 | 72201108 |
Device Lot Number | 50339492 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/24/2013
|
Initial Date FDA Received | 09/20/2016 |
Date Device Manufactured | 07/02/2010 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|