MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-02-20 for 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP 685-007 manufactured by Globus Medical, Inc..
[4358094]
In the process of trying to position a k-wire through "in-house" shorter and thinner jamshidi needles into where a revolve screw will be getting implanted (1) 1. 6mm x 500mm nitinol, blunt, threaded k-wire broke at the tip (appox 1cm) while inside the lumbar vertebral body, it was left inside the vertebral body.
Patient Sequence No: 1, Text Type: D, B5
[11773845]
A comprehensive investigation was immediately initiated on receipt of the complaint. The product was returned for eval; however a thorough review could not be conducted as the lot number was not provided. The k-wire was inspected, and has been broken at the distal end. The broken tip of the k-wire was left inside the pt. Based on the description, it is not possible to determine an exact cause for the reported issue. It is possible the k-wire became kinked from the screw and/or tap having a different trajectory when being inserted into the vertebra. This would subject the material to high forces, which would cause it to reach its elastic limit, and fracture. Nitinol is generally a safe biocompatible material and has been previously approved for long term implant use by the fda. The exact cause of the reported condition cannot be ascertained. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004142400-2014-00009 |
| MDR Report Key | 3772435 |
| Report Source | 07 |
| Date Received | 2014-02-20 |
| Date of Report | 2014-03-06 |
| Date of Event | 2014-03-05 |
| Date Mfgr Received | 2014-03-06 |
| Date Added to Maude | 2014-05-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DANIEL PAUL, VP |
| Manufacturer Street | 2560 GENERAL ARMISTEAD AVE. |
| Manufacturer City | AUDUBON PA 19403 |
| Manufacturer Country | US |
| Manufacturer Postal | 19403 |
| Manufacturer Phone | 6109301800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.6MM NITINOL K-WIRE, 500MM, BLUNT TIP |
| Generic Name | K-WIRE, 500MM |
| Product Code | PBF |
| Date Received | 2014-02-20 |
| Returned To Mfg | 2014-03-13 |
| Model Number | 685-007 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBUS MEDICAL, INC. |
| Manufacturer Address | 2560 GENERAL ARMISTEAD AVE. AUDUBON PA 19403 US 19403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-20 |