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.
[42989570]
(b)(4). The device was received for evaluation. The gripper would properly hold a. 0945" pin in the 2. 4mm hole and a. 1185 inch gage pin in the 3. 0mm hole. Elongation of hole feature was noted. Dents and scratches 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. The device showed heavy wear. During functional testing, the device allowed a 3mm guide wire to slip when heavy load was applied to the wire. Manufacturing records of the lot show that the device was manufactured within specification. The device was used for treatment. The probable cause for the elongation of hole feature is likely wear due to normal use. The gripper has a potential field age of approximately 2 years with an unknown number of uses. 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
[42989571]
It was reported that guide wire tensioner no longer tensions guide wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01113 |
| MDR Report Key | 5572531 |
| Date Received | 2016-04-12 |
| Date of Report | 2013-12-11 |
| Date of Event | 2013-12-06 |
| Date Mfgr Received | 2013-12-11 |
| Device Manufacturer Date | 2012-01-12 |
| 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 | 2014-01-29 |
| 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 | 2016-04-12 |