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 GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc,.
[42493437]
The device was returned for evaluation. The reported condition was confirmed. Visual inspection of the product concluded dents are visible on the top and bottom surfaces of the gripper, indicating previous use. Damage was also noted to the threads and wear and elongation was evident on the 3mm hole. Manufacturing records for this lot were reviewed and did not indicate any manufacturing anomalies. The guide wire grippers were dimensionally analyzed and found to be within specification where measured. The device was used for treatment. The cause of the complaint was likely due to the wear and elongation of the 3. 0mm hole in the pivot plate caused by normal use of the device over an extended amount of time. The gripper has a potential field age of over 4. 5 years with an unknown number of uses. This product will be monitored for any adverse complaint trends. 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
[42493438]
It was reported that the guide wire gripper does not have any more tension and does not hold the wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01033 |
| MDR Report Key | 5572494 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-04-12 |
| Date of Report | 2013-11-11 |
| Date Mfgr Received | 2013-11-11 |
| Device Manufacturer Date | 2009-02-25 |
| 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 | GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-04-12 |
| Returned To Mfg | 2013-12-16 |
| Catalog Number | 00249001200 |
| Lot Number | 61107858 |
| 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 |