Brand Name | GUIDE BOLT WRENCH |
Type of Device | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
Manufacturer (Section D) |
SMITH & NEPHEW, INC. |
1450 brooks road |
memphis TN 38116 |
|
MDR Report Key | 8098942 |
MDR Text Key | 128193482 |
Report Number | 1020279-2018-02561 |
Device Sequence Number | 1 |
Product Code |
HSB
|
UDI-Device Identifier | 03596010560469 |
UDI-Public | 03596010560469 |
Combination Product (y/n) | N |
PMA/PMN Number | K122170 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
01/23/2019 |
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 | 71631140 |
Device Lot Number | 07CM16174 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/08/2018 |
Initial Date Manufacturer Received |
11/02/2018 |
Initial Date FDA Received | 11/22/2018 |
Supplement Dates Manufacturer Received | 11/02/2018
|
Supplement Dates FDA Received | 01/23/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|