Brand Name | TWINFIX ULTRA 5.5MM W/3 UB |
Type of Device | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE / MBI |
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 |
james
gonzales
|
150 minuteman road |
andover, MA 01810
|
5123585706
|
|
MDR Report Key | 5386522 |
MDR Text Key | 36684852 |
Report Number | 1219602-2016-00040 |
Device Sequence Number | 1 |
Product Code |
MBI
|
Combination Product (y/n) | N |
PMA/PMN Number | K100159 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup,Followup |
Report Date |
06/14/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/01/2020 |
Device Catalogue Number | 72202897 |
Device Lot Number | 50542652 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/07/2017 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/31/2015
|
Initial Date FDA Received | 01/22/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 04/05/2016 06/14/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/23/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |