MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for ZIMMER ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42976001]
(b)(4). The returned device exhibits wear and tear that indicates use. A functional test was performed using 2. 5mm and 3. 0mm smooth guide wires. The device functioned as intended by holding sufficiently both the 2. 5mm and 3mm wires. There is some damage noted around the 3. 0mm hole as well as on the thread of the threaded rod. The product was measured against the print specifications at several dimensions and it was confirmed that all measurements taken were within specification. Device history records were reviewed and the records indicated that the device met specifications at the time of manufacture. The guide wire gripper had a potential field age of approximately 5 years and 3 months at the time of incident. The device is used for treatment. The package insert included specifies that the device may not perform as intended if damaged or worn. Although the device passed the functionality test, the guide wire gripper having wear damage on the threads and around the 3mm hole has potential to compromise the function of the device; therefore, the most likely cause of the instrument not gripping is wear and tear from 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
[42976002]
It is reported that the instrument failed to grip the guide wire during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01063 |
| MDR Report Key | 5569637 |
| Date Received | 2016-04-12 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-08-26 |
| Date Mfgr Received | 2015-09-03 |
| Device Manufacturer Date | 2010-07-13 |
| 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 | ZIMMER ZNN GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-04-12 |
| Returned To Mfg | 2015-10-21 |
| 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 IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |