MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-03 for PLATE-BENDING PRESS 329.30 manufactured by Synthes Usa.
[5559882]
The service and repair department documented that during an open reduction internal fixation (orif) of the humerus, the handle of the plate-bending press got stuck and wouldn't move up or down. Small particles of metal were observed wearing away at the arm joint of the device. After some saline lubrication the device started moving again but was still tight. Also the plate holding dish on the device would not raise or lower. Surgery delay was 1 minute before giving up and using manual hand benders. Surgery finished successfully without further complications. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12953208]
Device was used for treatment, not diagnosis. Additional narrative: device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Without a lot number the service history review could not be completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[13103875]
Additional narrative: a service history review was conducted. The report indicates that no service history review can be performed as this is a lot controlled item. The manufacture date of this item is unknown and cannot be traced. The service history evaluation is unconfirmed. Additional evaluation was conducted. The report indicates that the customer reported the arm joint was tight, and the anvil would not adjust. The repair technician reported the item was binding on the side of the arm joint, and the anvil was worn. Binding is the reason for repair. The cause of the issue is unknown. The following parts were replaced: lower anvil adjustment screw, small handle, ball (lid, 2). This item was repaired, passed synthes final inspection and returned to the customer on (b)(4) 2015. The evaluation was confirmed. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-11405 |
| MDR Report Key | 4565187 |
| Report Source | 05,07 |
| Date Received | 2015-03-03 |
| Date of Report | 2015-02-21 |
| Date of Event | 2015-02-21 |
| Date Mfgr Received | 2015-03-10 |
| Date Added to Maude | 2015-03-03 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATE-BENDING PRESS |
| Generic Name | INSTRUMENT,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-03-03 |
| Returned To Mfg | 2015-02-27 |
| Catalog Number | 329.30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-03 |