MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-08-30 for 2.0MM X 125MM GUIDE PIN GDW-890-00 manufactured by Ascension Orthopedics.
[2929456]
The reporter stated during a total metatarsal phalangeal joint (mpj) replacement using movement great toe instruments for hallux rigidus, as the doctor was passing the k-wire through the sizer, the k-wire from the set "kept shearing and leaving small metal ringlets in the pt. " all metal pieces were removed.
Patient Sequence No: 1, Text Type: D, B5
[10105909]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2012-00042 |
| MDR Report Key | 2724746 |
| Report Source | 05,07 |
| Date Received | 2012-08-30 |
| Date of Report | 2012-08-30 |
| Date Mfgr Received | 2012-07-13 |
| Date Added to Maude | 2012-12-17 |
| 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 | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.0MM X 125MM GUIDE PIN |
| Generic Name | MOVEMENT GREAT TOE INSTRUMENTS |
| Product Code | LZJ |
| Date Received | 2012-08-30 |
| Catalog Number | GDW-890-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-30 |