MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-02-18 for DISTAL RADIOULNAR JOINT PLATE ASSEMBLY DRUJ-P20 manufactured by Aptis Medical, Llc..
[2577483]
Two small radial plate cover screws backed out of their assembled position allowing the radial plate cover to come free from the radial plate. The device was returned and found to have no visual defects. The device was reassembled, all parts mated properly and functioned as designed. Factors during the procedure such as screws not sufficiently tightened and/or anatomy interposed between the mating surfaces of the device could have led to loosening of the screws. Based on the successful functional test results and discussions with the operator, the cause of this occurrence is likely inadequate tightening of the radial cover screws.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004521401-2009-00001 |
| MDR Report Key | 2518310 |
| Report Source | 05 |
| Date Received | 2009-02-18 |
| Date of Report | 2009-02-13 |
| Date of Event | 2008-12-19 |
| Date Mfgr Received | 2008-12-19 |
| Device Manufacturer Date | 2008-05-01 |
| 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 PLATE ASSEMBLY |
| Product Code | KXE |
| Date Received | 2009-02-18 |
| Returned To Mfg | 2009-01-14 |
| Model Number | DRUJ-P20 |
| Catalog Number | DRUJ-P20 |
| Lot Number | K10831 |
| ID Number | NA |
| Device Expiration Date | 2013-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APTIS MEDICAL, LLC. |
| Manufacturer Address | GLENVIEW KY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2009-02-18 |