Brand Name | RATCHET BIPASS SUTURE PASSER |
Type of Device | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
Manufacturer (Section D) |
BIOMET SPORTS MEDICINE |
56 e. bell drive |
warsaw IN 46582 |
|
Manufacturer (Section G) |
BIOMET ORTHOPEDICS |
56 e. bell drive |
|
warsaw IN 46582 |
|
Manufacturer Contact |
megan
haas
|
56 e. bell drive |
warsaw, IN 46582
|
5743726700
|
|
MDR Report Key | 5949560 |
MDR Text Key | 54683342 |
Report Number | 0001825034-2016-03612 |
Device Sequence Number | 1 |
Product Code |
HTD
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | PEXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Medical Equipment Company Technician/Representative
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
03/30/2017 |
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 |
Physician
|
Device Model Number | N/A |
Device Catalogue Number | 902099 |
Device Lot Number | 106590 |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/07/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/15/2016
|
Initial Date FDA Received | 09/14/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided
|
Supplement Dates FDA Received | 01/19/2017 03/21/2017 04/10/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/13/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |