MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[45095094]
(b)(4). As returned, the gripper does not properly grip a. 1185 inch gage pin in the 3. 0mm hole. The gripper would properly hold a. 0945" pin in the 2. 4mm hole and a. 1185 inch gage pin in the 3. 0mm hole. The gripper does not properly grip a. 1185 inch gage pin in the 3. 0mm hole with only the threaded rod being used to tighten it. Visual inspection concluded there are dents on the top and bottom surfaces of the gripper indicating previous use. Abrasion was also visible on the 3. 0mm holes in the handle and pivot plate. Damage was also noted to the teeth. Manufacturing records for the lot were reviewed and do not indicate any manufacturing anomalies. The guide wire grippers were dimensionally analyzed and found to be within specification where measured. The gripper has a potential field age of approximately 1. 5 years with an unknown number of uses. The 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 when fully stretched. Teeth damage might be due to wear and tear or excessive force applied on locking nut; however this cannot be confirmed. Elongation of the holes is probably wear due to normal use. 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
[45095095]
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 | 1822565-2016-01028 |
| MDR Report Key | 5650881 |
| Date Received | 2016-05-12 |
| Date of Report | 2013-10-24 |
| Date Mfgr Received | 2013-10-24 |
| Device Manufacturer Date | 2012-01-12 |
| Date Added to Maude | 2016-05-12 |
| 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 | 2016-05-12 |
| Returned To Mfg | 2013-12-19 |
| Catalog Number | 00249001200 |
| Lot Number | 61962249 |
| 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 | 2016-05-12 |