MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-05 for JARIT TOWNLEY FEMUR CALIPER 275-600 manufactured by Integra Lifesciences Corporation.
[5425430]
The calipers have both an inside and outside marking. However, positioning of the words and the way calipers are used can lead staff to provide the incorrect measurement during a surgical procedure. For this event, the femoral head explant was measured using the calipers on the outside edges of the implant. The markings at that time measured 38 outside and 46 inside. Scrub tech announced to the team 48 outside. Markings are confusing and not logical to think the outside measurement appears to be larger than the inside marking. It leads the individual to believe the larger marking is the outside measurement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4454584 |
| MDR Report Key | 4454584 |
| Date Received | 2015-01-05 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-11-11 |
| Report Date | 2014-12-03 |
| Date Reported to FDA | 2015-01-05 |
| Date Reported to Mfgr | 2015-01-27 |
| Date Added to Maude | 2015-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JARIT |
| Generic Name | TAPE, MEASURING, RULERS AND CALIPERS |
| Product Code | FTY |
| Date Received | 2015-01-05 |
| Model Number | TOWNLEY FEMUR CALIPER |
| Catalog Number | 275-600 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-05 |