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 2016-06-24 for GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer, Inc..
[48141691]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[48141692]
It is reported the grippers will not grip the wires.
Patient Sequence No: 1, Text Type: D, B5
[51474172]
This report is being amended to reflect changes in sections. This report will be amended when our investigation is complete. Received, not yet evaluated.
Patient Sequence No: 1, Text Type: N, H10
[55219276]
The returned product was confirmed to have wear that could potentially cause loss of function. As returned, the guide wire grippers exhibited wear and tear that indicates use. A functional test was performed using smooth guide wires. The device functioned as intended while using the first tested feature. The second tested feature did not grip and hold the guide wire. Dimensional measurements and material hardness are conforming to print specification. The device history records were reviewed and the records indicated that the device met specifications at the time of manufacture. The guide wire grippers had potential field ages of approximately 1 years and 2. 5 years at the time of the reported incident. This device was used for treatment. Initial product history search conducted on august 30, 2016 revealed no additional complaints against the related part and lot combinations. The package insert included with the instrument has instructions for use, warnings, and precautions for the instrument. Some of these instructions are? End of life is normally determined by wear and damage due to use. . . Do not use cutting/sharp instruments with dull or deformed edges or instruments/provisionals that are deformed, corroded, damaged or worn. They may not perform as intended. . . If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement.? The most likely cause of the instruments not gripping is wear and tear from use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2016-02181 |
| MDR Report Key | 5748742 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-06-24 |
| Date of Report | 2016-06-01 |
| Date of Event | 2016-05-23 |
| Date Mfgr Received | 2016-09-01 |
| Device Manufacturer Date | 2013-12-03 |
| Date Added to Maude | 2016-06-24 |
| 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 | GUIDE WIRE GRIPPER |
| Generic Name | TRAUMA INSTRUMENT |
| Product Code | HXI |
| Date Received | 2016-06-24 |
| Returned To Mfg | 2016-07-15 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 62550515 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-06-24 |