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 2016-05-06 for ZNN GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer, Inc..
[44612024]
Two guide wire grippers were sent in with this complaint for evaluation. Visual exams and functional tests were performed on both products. Manufacturing records and a technical evaluation showed the guide wire grippers were conforming to the specifications and material information sheet (mis). Both returned products show repeated use indicated by worn etching, dents and scratches, thread damage in one instrument, and guide wire hole damage in the other. The instruments had a potential field age of approximately 3. 5 years at the time of incident with unknown usage history. This device is used for treatment. A functionality test was run on both products and one lot passed and the other lot failed, with use of a 3. 0mm by 70cm guide wire. The failed product from the listed lot number is the part that exhibits hole elongation on both the top strike handle and the pivot plate. Based on information provided, the device has reached the end of its useful life. This issue has been investigated due to previous reports of this nature. A new design was released to increase the hardness of the strike plate and tighten the tolerance of the guide wire holes, which will improve gripping strength as well as durability. 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
[44612025]
It was reported that the guide wire grippers allow wire to slip through them; the guide wire grippers are not gripping properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2016-01476 |
| MDR Report Key | 5636960 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-05-06 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-03-10 |
| Date Mfgr Received | 2015-03-19 |
| Device Manufacturer Date | 2011-09-23 |
| Date Added to Maude | 2016-05-06 |
| 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 | MS. CARRIE SCHNEIDER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZNN GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-05-06 |
| Returned To Mfg | 2015-06-02 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 61571814 |
| ID Number | N/A |
| 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 | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-06 |