MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-07-01 for ASCENSION DRUJ DRUJ-610-1755 DRUJ-610-1755-WW manufactured by Ascension Orthopedics, Inc..
[2118710]
A distributor reported that a surgeon had trouble seating a druj implant. The surgeon identified the size of implant then started to impact the device and place it into the osteotomy. The surgeon reported that he was unable to seat the implant. He then spent 30 minutes trying to remove the implant to no avail. The surgeon made one last attempt to seat the implant and the ulna fractured. The surgeon closed the pt with the device in situ, sure that the fracture would heal. The doctor stated that the pt has a gap between the implant and the bone which he believes is causing a click during supination. He also stated that he believes that the implant in the box was larger than what was stated on the box and that there was a difference between the trial stem and the implant stem.
Patient Sequence No: 1, Text Type: D, B5
[9284345]
Mfg records that were reviewed did not identify what may have caused or contributed to this event. The investigation is ongoing. If add'l info is collected/determined, a supplemental report will be filed as appropriated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2011-00052 |
| MDR Report Key | 2156032 |
| Report Source | 08 |
| Date Received | 2011-07-01 |
| Date of Report | 2011-07-01 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-06-01 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2011-07-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEN THOMA |
| Manufacturer Street | 8700 CAMERON RD. |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal | 78754 |
| Manufacturer Phone | 5128365001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENSION DRUJ |
| Generic Name | WRIST JOINT ULNAR (HEMI-WRIST) PROSTHESIS |
| Product Code | KXE |
| Date Received | 2011-07-01 |
| Model Number | DRUJ-610-1755 |
| Catalog Number | DRUJ-610-1755-WW |
| Lot Number | 10-2530 |
| Device Expiration Date | 2014-09-01 |
| 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, INC. |
| Manufacturer Address | 8700 CAMERON RD. AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-07-01 |