MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42963026]
(b)(4). No devices or photos were received; therefore the condition of the components is unknown. Review of the device history record did not find any deviation or anomalies. The guide wire gripper was manufactured on 05/22/2013 and therefore had been in the field for approximately 3 years. It is unknown how many times the device had been used during that time. This device is used for treatment. A definitive root cause cannot be determined with the information provided. However, the complaint may be revised upon return of product or further information. This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
Patient Sequence No: 1, Text Type: N, H10
[42963027]
It was reported that the guide wire gripper does not hold the wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01079 |
| MDR Report Key | 5566568 |
| Date Received | 2016-04-11 |
| Date of Report | 2015-04-09 |
| Date Mfgr Received | 2015-04-09 |
| Device Manufacturer Date | 2013-05-22 |
| Date Added to Maude | 2016-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-04-11 |
| Catalog Number | 00249001200 |
| Lot Number | 62314682 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | PO BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-11 |