MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-12 for VERSA-FX FEMORAL LINKED LAG SCREW INSERTER 00119301200 manufactured by Zimmer Inc.
[42491658]
(b)(4). Two lag screw inserters were returned and confirmed to be fractured. Visual exam noted both lag screw inserters to be fractured at the distal end that is to be inserted into bone. Device history record review of lag screw inserters found conformed. The first inserter has a potential field age of roughly 3 years. The second inserter has a potential field age of over 6. 5 years. Print specifications were met on all devices where measured. The device is used for treatment. Previous investigation through scanning electron microscopy (sem) has found the failure mode to likely be caused by torque overload. 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
[42491659]
It was reported that during a versa fx trauma surgery, a lag screw inserter and inserter rod broke while implanting the lag screw. A second inserter was then flash sterilized from another set for use, and it broke as well. The surgeon then switched from a 3-hole keyed implant to a 4-hole keyless implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2016-01161 |
| MDR Report Key | 5572071 |
| Date Received | 2016-04-12 |
| Date of Report | 2014-03-14 |
| Date of Event | 2014-03-14 |
| Date Mfgr Received | 2014-03-14 |
| Device Manufacturer Date | 2007-07-19 |
| 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 | VERSA-FX FEMORAL LINKED LAG SCREW INSERTER |
| Generic Name | KWR |
| Product Code | KWR |
| Date Received | 2016-04-12 |
| Returned To Mfg | 2014-03-25 |
| Catalog Number | 00119301200 |
| Lot Number | 60744853 |
| 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 | 1. Other | 2016-04-12 |