MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42979512]
(b)(4). Dents are visible on the top and bottom surfaces of the gripper indicating previous effective use. Abrasion was also visible on the 3. 0mm holes in the handle and pivot plate. Damage was also noted to the threads. The guide wire grippers were dimensionally analyzed and found to be within specification where measured. This device was used for treatment. The damage on the locking teeth might have contributed to the gripping condition. Due to the damage on the teeth, the gripper was not able to lock at fully stretched condition. The probable cause for the elongation of hole feature is likely wear due to normal use and teeth damage might be due to wear and tear or excessive force applied on locking nut; however this cannot be confirmed with available information. The gripper has a potential field age of approximately 1. 5 years with an unknown number of uses. The device has reached the end of its useful life. This failure mode has been identified as a reoccurring complaint. A new design was released to increase the hardness of the strike plate and tighten 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
[42979513]
It was reported that the guide wire gripper allows wire to slip through it, and is not gripping properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01184 |
| MDR Report Key | 5569581 |
| Date Received | 2016-04-12 |
| Date of Report | 2015-01-09 |
| Date Mfgr Received | 2015-01-09 |
| Device Manufacturer Date | 2012-02-22 |
| 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 | ZNN GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-04-12 |
| Returned To Mfg | 2015-02-05 |
| Catalog Number | 00249001200 |
| Lot Number | 62006692 |
| 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 |