MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-21 for PLATE-BENDING PRESS 329.30 manufactured by Synthes Usa.
[60438124]
No patient involvement reported. Date of event is unknown. (b)(4). Device is an instrument and is not implanted / explanted. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Reporter contact number: (b)(6). No service history review can be performed because the lot/serial number is unknown and cannot be traced. The manufacture date is unknown. The service history review is unconfirmed. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Device history records review could not be completed without lot number. Device 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
[60438125]
(b)(6) reported that a plate bending press was found broken or non-functioning by the hospital facility. There is no reported patient or procedure involvement. This report is for one (1) plate-bending press. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[63932930]
Service and repair evaluation was completed. The customer reported the item was broken. The repair technician reported the pressure roller was sticking. Binding is the reason for repair. The cause of the issue is unknown. The following parts were replaced: main body, pressure bolt, lower anvil, lower anvil adjustment screw, pin, screw with spring (2). The item was repaired per the inspection sheet, passed synthes final inspection on (b)(6) 2016 and will be returned to the customer upon completion of the service and repair process. 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 | 2520274-2016-15454 |
| MDR Report Key | 6116409 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-21 |
| Date of Report | 2016-10-30 |
| Date Mfgr Received | 2016-11-29 |
| Date Added to Maude | 2016-11-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATE-BENDING PRESS |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2016-11-21 |
| Returned To Mfg | 2016-11-29 |
| 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 | 2016-11-21 |