MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-04-23 for PLATE-BENDING PRESS 329.30 manufactured by Synthes Usa.
[18652786]
It was reported that when the plate-bending press handle is moved up and down it is shaving off metal and misaligned. This was found while pre-bending a plate prior to surgery, no surgery or patient involved. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18820601]
Event date: unknown. Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A review of the service history records has been requested. 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
[27680551]
A service history record review could not be performed because the reported lot number could not be validated or traced. A service and repair evaluation was performed for the subject device. The customer reported the handle was misaligned. The repair technician reported the item was worn out. ? Worn out parts? Are the reason for repair. The cause of the issue is unknown. The following parts were replaced: main body complete, pressure bolt complete, off-center cam, shaft extension handle, grip handle, upper anvil, lower anvil, lower anvil adjustment screw, and screw with spring. This item was repaired, passed synthes final inspection and returned to the customer on 27-apr-2015. The evaluation was confirmed. 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 | 2520274-2015-13384 |
| MDR Report Key | 4723922 |
| Report Source | 05,07 |
| Date Received | 2015-04-23 |
| Date of Report | 2015-04-08 |
| Date Mfgr Received | 2015-04-29 |
| Date Added to Maude | 2015-04-23 |
| 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 | 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 | 2015-04-23 |
| Returned To Mfg | 2015-04-14 |
| Catalog Number | 329.30 |
| Lot Number | XXXXXNA |
| 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 | 2015-04-23 |