MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42984295]
(b)(4). Information was received from a distributor who is not required to complete form 3500a. Device return condition noted impact damage on the impaction zones on top and bottom of the product. Threads were damaged and a few scratches were along the side of the product. The device met print specifications where measured. For functional testing, 3. 0 and 2. 4 mm guide wires were placed in a vice and the guide wire gripper was locked down on the guide wire and hit with a mallet. In both cases the guide wire gripper slid down the guide wire. Device history records review found lot conformed at the time of manufacture. The approximate lifetime of the device is 4 years. It is unknown how many times device was used during that timespan. The device is used for treatment. The root cause of the complaint appears due to normal wear to the device over its approximate 4 year lifetime. The device reached the end of its useful life. 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
[42984296]
It was reported during surgery, the guide wire gripper was not functioning properly and would not tension wires as expected. Cannot be properly jammed and slides through guide wires. In addition, subcomponents on the instrument appear to be loosened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01199 |
| MDR Report Key | 5570014 |
| Date Received | 2016-04-12 |
| Date of Report | 2016-06-11 |
| Date Mfgr Received | 2014-06-11 |
| Device Manufacturer Date | 2010-07-13 |
| Date Added to Maude | 2016-04-12 |
| 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 | P.O. 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 | 2016-04-12 |
| Returned To Mfg | 2014-07-11 |
| Catalog Number | 00249001200 |
| Lot Number | 61571812 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |