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 2016-04-12 for ZIMMER ZNN GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42438896]
Information was received from a surgeon who is not required to complete form 3500a. The product was returned for evaluation. Photo and visual examinations reported normal wear and cosmetic damage on the product. Product was showing signs of tool marks on both the top and bottom indicating use. The 3. 0mm hole was found to be worn and slightly out of shape. The 2. 4mm hole was not worn, as it was likely used less frequently. Upon inspection, worn evidence was also noted by thread damage where the product locks in place. Functional tests and measurements performed on the product by methods; such as, pin gages, caliper, rockwell hardness test, and micrometer. All dimensions measured met print specifications. The device history records reviewed found device to be conforming at the time of manufacture. The device is roughly 3. 5 years old. This device is used for treatment. The most likely cause of the instrument not gripping is normal wear from use; the device has reached the end of its useful life. 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
[42438897]
It was reported that the guide wire gripper no longer gripped 3. 0mm guide wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01037 |
| MDR Report Key | 5569524 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-04-12 |
| Date of Report | 2014-02-17 |
| Date of Event | 2014-02-13 |
| Date Mfgr Received | 2014-02-17 |
| Device Manufacturer Date | 2010-08-15 |
| 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 | 3 |
| Brand Name | ZIMMER ZNN GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-04-12 |
| Returned To Mfg | 2014-03-28 |
| Catalog Number | 00249001200 |
| Lot Number | 61571817 |
| 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 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |