MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for ZIMMER NATURAL NAIL GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer, Inc..
[44576675]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[44576676]
It is reported the guide wire gripper would not engage and grip the guide wire during use in surgery.
Patient Sequence No: 1, Text Type: D, B5
[47896581]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[55580066]
Device history records were previously reviewed with no deviations or anomalies identified that would have contributed to the reported event. Product was returned for evaluation. Visual inspection revealed thread damage on the threaded rod. Two pins were identified to be loose. Impact marks were visible on both the superior and inferior surface. Dimensions were found conforming to print specifications where measured. The hardness of the top strike handle was found to be conforming. This device is used for treatment. The device had a potential field age of approximately four years. It is also unknown how many times the device had been used during that time. A definitive root cause cannot be determined with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2016-01388 |
| MDR Report Key | 5627603 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-09-13 |
| Device Manufacturer Date | 2012-02-22 |
| Date Added to Maude | 2016-05-03 |
| 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 | ZIMMER NATURAL NAIL GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-05-03 |
| Returned To Mfg | 2016-05-26 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 62006692 |
| 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 | 2016-05-03 |