MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-06 for CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT 9159-3045 manufactured by Arthrosurface, Inc..
[42640718]
Evaluation summary: the device was returned and the complaint was confirmed. Arthrosurface engineering department inspected and tested the instrument. The reamer did function as intended without any issues. Engineering personnel spoke with the surgeon regarding the results of the testing. A rm of arthrosurface shall attend the future cases of this surgeon. As of submission date, the patient is doing well with no issues. The complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
[42640719]
The event occured during a hemicap mtp df surgery. Surgeon was almost complete. But did not think he was quite deep enough on the metatarsal head. He continued to ream and fractured the metatarsal head. Surgeon asked if the reamer is dull. Arthrosurface has been notified of the issue on the same day of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004154314-2016-00009 |
| MDR Report Key | 5550453 |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-03-08 |
| Date Mfgr Received | 2016-03-08 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2016-04-06 |
| 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 | MR. PHANI PUPPALA |
| Manufacturer Street | 28 FORGE PARKWAY |
| Manufacturer City | FRANKLIN MA 02038 |
| Manufacturer Country | US |
| Manufacturer Postal | 02038 |
| Manufacturer Phone | 5085203003 |
| Manufacturer G1 | PRIMO MEDICAL GROUP |
| Manufacturer Street | 75 MILL ST. |
| Manufacturer City | STOUGHTON MA 02072 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT |
| Generic Name | TOE JOINT PHALANGEAL (HEMI-TOE) POLYMER PROSTHESIS |
| Product Code | KWD |
| Date Received | 2016-04-06 |
| Returned To Mfg | 2016-03-16 |
| Catalog Number | 9159-3045 |
| Lot Number | 75JE1416 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHROSURFACE, INC. |
| Manufacturer Address | 28 FORGE PARKWAY FRANKLIN MA 02038 US 02038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-06 |