MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for VILEX HEMI IMPLANT CHI-2CH manufactured by Vilex In Tennessee, Inc..
[101259239]
Received call on (b)(6) 2018 from account manager that the wire could not be removed from an implant. Following surgical technique surgeon inserted the guidewire and used trial sizer to determine correct size of the implant need. Size was determined. Surgeon slid the implant over the guidewire and began advancing the implant. Before completely tighten the surgeon removed the driver and attempted to remove the guidewire. Surgeon tried removing the wire by holding down on the implant while pulling the wire. While doing so, he pulled the implant out of the canal. Once removed surgical tech tried to remove the wire from the implant and was unsuccessful. Implant-wire were cleaned and returned to vilex. January 24, 2018, vilex received the implant-wire from the account manager. January 31, 2018, vilex's quality department examined the implant-wire. The wire was found to be stuck at the insertion tip. Quality personnel was able to remove the wire from the implant. Wire size was checked and found to be 1. 6mm. Implant cannulation was checked with a 1. 6mm gage pin. No problem was found. Upon examining the wire, he found it to be bent. Wire also had nicks which could have possibly been from the wire driver used during surgery. It is believed the surgeon did not predrill the canal as he stated he inserted the wire and started driving the implant. As with any cannulated implant, the cannulation and the wire size depends on the wire being straight and the cannulation of the implant sliding freely over the wire. If the wire is bent during insertion, the implant cannot slide over the bend in the wire and will become galled to the implant. If more information becomes available a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[101259240]
Received call on (b)(6) 2018 from account manager that surgeon had an issue removing the guidewire from the implant once it was partially implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051526-2018-00001 |
| MDR Report Key | 7301590 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-01-31 |
| Date of Event | 2018-01-22 |
| Date Facility Aware | 2018-01-22 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2012-05-07 |
| Date Added to Maude | 2018-02-27 |
| 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 | SYLVIA SOUTHARD |
| Manufacturer Street | 111 MOFFITT STREET |
| Manufacturer City | MCMINNVILLE TN 37110 |
| Manufacturer Country | US |
| Manufacturer Postal | 37110 |
| Manufacturer Phone | 9314747550 |
| Manufacturer G1 | VILEX IN TENNESSEE, INC. |
| Manufacturer Street | 111 MOFFITT STREET |
| Manufacturer City | MCMINNVILLE TN 37110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VILEX HEMI IMPLANT |
| Generic Name | CHI IMPLANT |
| Product Code | KWD |
| Date Received | 2018-02-27 |
| Returned To Mfg | 2018-01-24 |
| Model Number | CHI-2CH |
| Lot Number | 5269 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VILEX IN TENNESSEE, INC. |
| Manufacturer Address | 111 MOFFITT STREET MCMINNVILLE 37110 US 37110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-27 |