MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-02-16 for DEPTH GAUGE 303407 manufactured by Integra Lifesciences Corporation Oh/usa.
[2487836]
The reporter stated that during a total wrist fusion surgery procedure using the integra total wrist fusion system instrumentation set, the surgeon could not read the markings on the depth gauge, even using loupes. Several screws had to be removed because the surgeon was left to estimate the length of the screws, take radiographs and then estimate the adjusted required size.
Patient Sequence No: 1, Text Type: D, B5
[9649668]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2012-00030 |
| MDR Report Key | 2472940 |
| Report Source | 05,07 |
| Date Received | 2012-02-16 |
| Date of Report | 2012-02-16 |
| Date of Event | 2012-01-31 |
| Date Mfgr Received | 2012-01-31 |
| Date Added to Maude | 2012-08-22 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPTH GAUGE |
| Generic Name | WRIST FUSION INSTRUMENTS |
| Product Code | EIL |
| Date Received | 2012-02-16 |
| Catalog Number | 303407 |
| Lot Number | WRISTFUSE 10 TRAY LOT NUMBER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-02-16 |