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 2016-09-19 for ZIMMER ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer, Inc..
[55048046]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[55048047]
It was reported that the guide wire gripper was not holding well during surgery.
Patient Sequence No: 1, Text Type: D, B5
[57955808]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[57955809]
It was reported that the guide wire gripper was not holding well prior to surgery. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[60117979]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[61003910]
The guidewire gripper was returned for review. Visual inspection revealed impact marks on the superior surface. A functional check confirmed that the 2. 4mm hole securely gripped a guide wire, but the 3. 0 mm hole failed to securely grip a guide wire. The threaded locking knob was also observed to bind. Device history records were reviewed for the device and identified no deviations or anomalies. This device is used for treatment. Based on the order running complete, it is believed the part was conforming when it left zimmer biomet. The instrument/provisional use, care and sterilization package insert states to inspect all product and? 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 guidewire gripped was manufactured on january 30, 2014 and therefore had potential field ages of approximately 2 years 7 months, with the exact usage unknown. 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 | 0001822565-2016-03293 |
| MDR Report Key | 5960192 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-09-19 |
| Date of Report | 2016-08-23 |
| Date of Event | 2016-08-23 |
| Date Mfgr Received | 2016-11-21 |
| Device Manufacturer Date | 2014-01-30 |
| Date Added to Maude | 2016-09-19 |
| 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 ZNN GUIDE WIRE GRIPPER |
| Generic Name | TRAUMA INSTRUMENT |
| Product Code | HXI |
| Date Received | 2016-09-19 |
| Returned To Mfg | 2016-10-25 |
| Catalog Number | 00249001200 |
| Lot Number | 62597689 |
| 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 | 2016-09-19 |