MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-08-28 for MCP SZ. 40 PROXIMAL WW MCP-100-40P-WW manufactured by Ascension Orthopedics.
[4719494]
It was reported during a two joint pyrocarbon mcp surgical case, the shaft of a size 40 proximal mcp joint fractured mid stern, in the intramedullary canal. It took extra time to remove the fractured implant. A spare device was available and used to complete the surgery. There was no injury to the patient reported. The surgery time was increased 20 minutes.
Patient Sequence No: 1, Text Type: D, B5
[12352571]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00043 |
| MDR Report Key | 4102668 |
| Report Source | 05,06,07 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-08-01 |
| Date of Event | 2014-08-01 |
| Date Mfgr Received | 2014-08-01 |
| Date Added to Maude | 2014-09-29 |
| 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 FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP SZ. 40 PROXIMAL WW |
| Product Code | NEG |
| Date Received | 2014-08-28 |
| Returned To Mfg | 2014-08-08 |
| Catalog Number | MCP-100-40P-WW |
| Lot Number | 13-0086 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2014-08-28 |