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.
[42984306]
Information was received from a distributor who is not required to complete form 3500a. Device was returned for exam. The product received condition was described as light cosmetic damage. One device was returned with scratches on the top and bottom indicative of use. Thread damage was noted where the product can be locked in place to hold a guidewire. The 3. 0mm and 2. 4mm holes did not appear worn or damaged during visual inspection without magnification. The wire grippers were evaluated by visual examination, dimensional analysis, and functional tests; such as, visual, pin gages, micrometer, caliper and rockwell hardness test. Print specifications were met for device. Device history records were previously reviewed and found conforming to requirements at the time of manufacture. Lot was previously reviewed and found conforming per complaint. The device is roughly 5 years old. The device is used for treatment. The device has reached the end of its useful life. This failure mode has been previously reported. A new design is being tested that increases the hardness of the strike plate and tightens the tolerance of the guide wire hole. This will provide additional useful life from the device. 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
[42984307]
It was reported that the guide wire gripper no longer tightens the guide wires as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01160 |
| MDR Report Key | 5571319 |
| Date Received | 2016-04-12 |
| Date of Report | 2014-03-19 |
| Date Mfgr Received | 2014-03-19 |
| Device Manufacturer Date | 2009-04-09 |
| 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 | 2014-04-18 |
| Catalog Number | 00249001200 |
| Lot Number | 61231404 |
| 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 |