MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer Inc.
[42991796]
(b)(4). Device returned condition was noted as: visible dents on surfaces of the gripper indicating previous effective use; abrasion visible on 3. 0mm holes of handle and pivot plate which were elongated; threads damaged; and handle showed signs of wear by noted dents and scuffs. Review of device history records review found no anomalies. Guide wire grippers were dimensionally analyzed and met print specification, including hardness testing. Due to damage on the teeth, the gripper was noted to be unable to lock at fully stretched condition. This device is used for treatment. The damage on the locking teeth may have contributed to the gripping condition. Probable cause of elongation of the hole feature is likely wear due to normal use and teeth damage might be due to wear and tear or excessive force applied on locking nut but this cannot be confirmed with available information. The gripper has a potential field age of approximately 1. 5 years with an unknown number of uses. 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
[42991797]
It is reported during surgery, the guide wire gripper no longer holds 3. 0 mm guide wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01212 |
| MDR Report Key | 5571481 |
| Date Received | 2016-04-12 |
| Date of Report | 2014-08-15 |
| Date Mfgr Received | 2014-08-15 |
| Device Manufacturer Date | 2012-02-22 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | GUIDE WIRE GRIPPER |
| Generic Name | HXI |
| Product Code | HXI |
| Date Received | 2016-04-12 |
| Returned To Mfg | 2014-09-29 |
| Catalog Number | 00249001200 |
| Lot Number | 62006692 |
| 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 |