MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-11 for VISIONAIRE V0100021 manufactured by Smith & Nephew, Inc., Orthopaedic Div.
[1280658]
It has been reported that surgery time was extended due to the surgeon having issues fitting the tibial cutting block. The complaint for this mdr was originally determined to be not reportable until updated info from the sales rep made us aware that the surgery time was extended.
Patient Sequence No: 1, Text Type: D, B5
[8453571]
Pulled and reviewed shop order paperwork. All paperwork was complete and correct. Completed scan of articular surface of parts, and both parts were acceptable. Completed dimensional inspection of part, and only concern was the slot on the tibia cutting block. It was over tolerance by. 006", and this could be due to the surgeon cutting into the part with the sawblade; the paperwork showed that at final inspection, the part was acceptable. Engineering also completed an investigation into the complaint and determined that the issues were due to mri image distortion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2010-00041 |
| MDR Report Key | 1601365 |
| Report Source | 07 |
| Date Received | 2010-02-11 |
| Date of Report | 2010-02-11 |
| Date of Event | 2009-11-06 |
| Date Mfgr Received | 2009-11-13 |
| Date Added to Maude | 2010-02-19 |
| 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 | MRS. LEAH EASLEY |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996137 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISIONAIRE |
| Generic Name | TIBIAL CUTTING BLOCK / EKD |
| Product Code | EKD |
| Date Received | 2010-02-11 |
| Returned To Mfg | 2009-11-12 |
| Model Number | NA |
| Catalog Number | V0100021 |
| Lot Number | PM003260-2 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-02-11 |