Brand Name | HOLDER, NEEDLE; ORTHOPEDIC |
Type of Device | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, HALSEY NEEDLEHOLDER FINE TC |
Manufacturer (Section D) |
BIOMET MICROFIXATION |
1520 tradeport drive |
jacksonville FL 32218 |
|
Manufacturer (Section G) |
BIOMET MICROFIXATION |
1520 tradeport drive |
|
jacksonville FL 32218 |
|
Manufacturer Contact |
michelle
cole
|
1520 tradeport drive |
jacksonville, FL 32218
|
9047414400
|
|
MDR Report Key | 6567366 |
MDR Text Key | 75215681 |
Report Number | 0001032347-2017-00389 |
Device Sequence Number | 1 |
Product Code |
HXK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | PN/A |
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,Followup |
Report Date |
05/15/2017 |
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 |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 51-6502 |
Device Lot Number | UNKNOWN |
Other Device ID Number | N/A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/21/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/17/2017 |
Initial Date FDA Received | 05/15/2017 |
Supplement Dates Manufacturer Received | 07/20/2017
|
Supplement Dates FDA Received | 07/28/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |