MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-11 for ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42533299]
(b)(4). Visual inspection of the device confirms that there are gouges and burrs on the top and bottom surfaces of the handle. It has also been noted that there is slight damage on the threaded rod and very small abrasion visible on the 3. 0 mm hole. Functional test was done using gauge pins that represent the diameter of 2. 4mm and 3. 0mm guide wires. The 2. 4mm feature functioned as intended while the 3. 0mm feature did not hold the gauge pin as intended. Review of the device history record did not find any deviations or anomalies. Dimensions were found conforming to print specifications where measured. Hardness testing confirms the hardness to be within specification. The device had been in the field for approximately 4 years 10 months. It is unknown how many times the devices had been used during that time. The damage on the threaded rod locking teeth might have contributed to the gripping condition. The hole damage is likely from wear due to repeated usage. A new design was released to increase hardness of the strike plate and tighten the tolerance of the guide wire holes. The goal of these changes is to improve gripping strength as well as durability which will provide additional useful life from the device. The device in this complaint was manufactured before the design change. It is likely that the damage is a result of wear during normal field life. 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
[42533300]
It is reported that the instrument failed to grip the guide wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01095 |
| MDR Report Key | 5568011 |
| Date Received | 2016-04-11 |
| Date of Report | 2015-06-24 |
| Date of Event | 2015-06-22 |
| Date Mfgr Received | 2015-06-24 |
| Device Manufacturer Date | 2010-08-14 |
| 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 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 | 2016-04-11 |
| Returned To Mfg | 2015-08-04 |
| Catalog Number | 00249001200 |
| Lot Number | 61571817 |
| 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 | 2016-04-11 |