MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-04-11 for GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc..
[42267468]
Dents and scratching are visible on the top and bottom striking surfaces of the gripper indicating previous effective use. Slight abrasion was observed around the guide wire holes on the device. Damage was also noted to the threads of the threaded rod. Damage was noted to the locking teeth. Previous review of manufacturing records indicated the device was conforming to specifications at the time of manufacture. The guide wire grippers were found to be within specification where measured. This device is used for patient treatment. The damage on the locking teeth may have contributed to the guide wire sliding through the holes, as exhibited during the functionality test. The probable cause for the elongation of guide wire 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 four years with an unknown number of uses. The device has reached the end of its useful life. Due to previous reports, a new design was released to increase the hardness of the strike plate and tighten tolerance of the guide wire hole. 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
[42267469]
It was reported the guide wire gripper would not grip guide wire to pull on as instrument is intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01023 |
| MDR Report Key | 5566581 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-04-11 |
| Date of Report | 2014-09-11 |
| Date Mfgr Received | 2014-09-11 |
| Device Manufacturer Date | 2010-07-13 |
| 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 | P.O. BOX 708 |
| Manufacturer City | WARSAW 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-04-11 |
| Returned To Mfg | 2014-11-18 |
| 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 IL 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-11 |