MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-06 for MCP SZ. 40 DISTAL WW MCP-100-40D-WW manufactured by Ascension Orthopedics.
[116719965]
The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed. However, from the description of failure, it is consistent with a rapid brittle, bending fracture, the root cause may be to excessive force applied to the device or to impacting an unsupported head, where the stem cannot be fully inserted into the medullary canal as has been seen in other reports. There were no deviations or non-conformances during the manufacturing process. In addition, the device history record review confirmed the labeling, material, and process controls were within specification. Link to: mfg report number 1651501-2018-00049.
Patient Sequence No: 1, Text Type: N, H10
[116719966]
Two (2) of 2 reports. A physician reported that on (b)(6) 2018, an mcp-100-40p-ww mcp proximal ww implant broke mid shaft while in metacarpal canal. There was part of the implant left in the patient and it was recovered by using a threaded k-wire. The surgeon worked to remove the broken implant piece by piece. Once the implant was recovered the surgeon was able to put a new implant in without any problem. The broken implant did not cause any other complications for the patient. As well, the patient is expected to have no further complications during recovery. Additional information received indicated that the event lead to 1 hour surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00050 |
| MDR Report Key | 7753772 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-06 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-07-03 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-08-06 |
| 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 VIVIAN NELSON |
| 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. 40 DISTAL WW |
| Generic Name | MCP |
| Product Code | NEG |
| Date Received | 2018-08-06 |
| Catalog Number | MCP-100-40D-WW |
| Lot Number | 173841T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-08-06 |