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 2016-10-14 for ZIMMER ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer, Inc..
[57495907]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[57495908]
It is reported that during surgery, the guide wire gripper would not grip the guide wire. An alternate gripper was used.
Patient Sequence No: 1, Text Type: D, B5
[60683316]
Patient Sequence No: 1, Text Type: N, H10
[63821215]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. The returned product was confirmed to have wear that could potentially cause loss of function. As returned, the guide wire gripper exhibited wear and tear that indicates use. A functional test was performed using 2. 4mm and a 3. 0mm smooth guide wires. The device functioned as intended while using the 2. 4mm feature. The 3. 0mm feature did not grip and hold the 3. 0mm guide wire. The 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 1. 5 years at the time of the reported incident. This device is used for treatment. Initial product history search conducted revealed no additional complaints against the related part and lot combination. Per the package insert for the instrument,? 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 | 0001822565-2016-03673 |
| MDR Report Key | 6031262 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-10-14 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2016-11-29 |
| Device Manufacturer Date | 2015-03-23 |
| Date Added to Maude | 2016-10-14 |
| 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. KATHLEEN SMITH |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER ZNN GUIDE WIRE GRIPPER |
| Generic Name | TRAUMA INSTRUMENT |
| Product Code | HXI |
| Date Received | 2016-10-14 |
| Returned To Mfg | 2016-10-25 |
| Catalog Number | 00249001200 |
| Lot Number | 63017696 |
| 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 | 2016-10-14 |