MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for ZIMMER ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42984465]
(b)(4. ) information was received from a foreign source who is not required to complete form 3500a. Evaluation of the returned instrument noted scratches on the top and bottom indicating use; thread damage was noted where the product clamps into place, with some discoloration was found on the device sides. The 3. 0mm and 2. 4mm holes were not found to be worn or mis-shapen during visual exam. Device history record reviews found lot conformed at the time of manufacture as part of this investigation the lot was re-reviewed and found conforming. The wire grippers were also evaluated by dimensional analysis, hardness test and functional tests. Device met print specifications and was noted to be roughly 1. 5 years old. It is unknown how many times the device was used. The device is used for treatment. The root cause of the complaint is normal wear to the device over its 1. 5 year lifetime. 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
[42984466]
It was reported that during surgery, the guide wire gripper did not fasten over the 3. 0 mm guide wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01068 |
| MDR Report Key | 5571348 |
| Date Received | 2016-04-12 |
| Date of Report | 2014-03-19 |
| Date of Event | 2014-03-15 |
| Date Mfgr Received | 2014-03-19 |
| Device Manufacturer Date | 2012-12-17 |
| Date Added to Maude | 2016-04-12 |
| 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 | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZIMMER ZNN GUIDE WIRE GRIPPER |
| Generic Name | HWI |
| Product Code | HXI |
| Date Received | 2016-04-12 |
| Returned To Mfg | 2014-04-18 |
| Catalog Number | 00249001200 |
| Lot Number | 62235899 |
| 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 | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |