MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-16 for DISTAL RADIOULNAR JOINT ASSEMBLY DRUJ-P30 manufactured by Aptis Medical, Llc..
[2598776]
Two small screws which comprise parts of a distal radioulnar joint prosthesis loosened from their assembled position inside the distal forearm of a pt. This required a re-operation to reassemble the device. The screws were inspected by the surgeon during the procedure and found to be functioning as intended. To allow further inspection of the screws, they were replaced and the device was reassembled.
Patient Sequence No: 1, Text Type: D, B5
[9950002]
After receiving the screws, they were visually inspected for defects including stripped threads and/or stripped heads. Both screws were undamaged and functioned as designed when applied to test pieces. Factors possibly allowing the loosening of the screw include, anatomy interposed between the mating surfaces of the device during assembly. Insufficient tightened of the screws during initial assembly. Stress exceeding recommendations during use of the device. The pt is an avid golfer and was informed prior to initial implantation of the device that care should be taken to limit stresses on the device. The pt admitted to the surgeon, golfing on a frequent basis and high force ground strikes during play. The known incidence of occurrence at this time is less the 1% of implanted devices, the possible factors will be discussed with using physicians and continued monitoring will proceed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004521401-2009-00002 |
| MDR Report Key | 2518311 |
| Report Source | 05 |
| Date Received | 2009-03-16 |
| Date of Report | 2009-03-13 |
| Date of Event | 2009-02-17 |
| Date Mfgr Received | 2009-02-17 |
| Date Added to Maude | 2012-04-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BARBARA CHESHER |
| Manufacturer Street | 3602 GLENVIEW AVE. |
| Manufacturer City | GLENVIEW KY 40025 |
| Manufacturer Country | US |
| Manufacturer Postal | 40025 |
| Manufacturer Phone | 5025236738 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISTAL RADIOULNAR JOINT ASSEMBLY |
| Product Code | KXE |
| Date Received | 2009-03-16 |
| Returned To Mfg | 2009-02-19 |
| Model Number | DRUJ-P30 |
| Catalog Number | DRUJ-P30 |
| Lot Number | K08520 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APTIS MEDICAL, LLC. |
| Manufacturer Address | LOUISVILLE KY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-03-16 |