MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for MCP SZ. 30 PROXIMAL WW MCP-100-30P-WW manufactured by Ascension Orthopedics.
[31450006]
It was reported the device broke during a procedure. A (b)(6) male patient was undergoing a mcp arthroplasty procedure on (b)(6) 2015. The surgeon inserted the implant into the second finger of the right hand. It did not fit properly so he took the implant out/off and noticed part of the stem had broken off. The surgeon decided to use the broken implant, as there were no additional implants to use. It was reported no patient injury is alleged.
Patient Sequence No: 1, Text Type: D, B5
[32618832]
Integra has completed their internal investigation on 11/02/2015. The investigation included: methods: review of device history records, review of complaints history. Results: the device remained implanted; therefore, it is not available for failure analysis. The review of manufacturing records showed no evidence of nonconformance that could have caused or contributed to the reported defect. A review of complaints for mcp implant fractures (both intra-op and post-op) during the last 5 years showed (b)(4) complaints. (b)(4). Conclusion: the investigation determined that possible causes of the fracture are most likely excessive force applied to the implant on insertion, or impacting an unsupported head when the stem cannot be fully inserted into the medullary canal due to an improperly prepared oblique osteotomy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2015-00037 |
| MDR Report Key | 5223433 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-10-23 |
| Date of Event | 2015-10-23 |
| Date Mfgr Received | 2015-11-02 |
| Device Manufacturer Date | 2014-12-08 |
| Date Added to Maude | 2015-11-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP SZ. 30 PROXIMAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2015-11-13 |
| Catalog Number | MCP-100-30P-WW |
| Lot Number | 142689T |
| 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 | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-13 |