MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-07-22 for PLATE-BENDING PRESS 329.30 manufactured by Synthes Usa.
[50297181]
(b)(4). Device is an instrument and is not implanted/explanted. 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. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[50297182]
It was reported that the plate-bending press will not press and pins looked broken. Issue was found during an unknown surgery. The surgeon had a back-up device to complete the surgery. The procedure was completed successfully with no reports of delay or medical intervention. The patient's post-operative status was noted to be stable. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[52621442]
A service and repair evaluation was completed: the customer reported the item would not press and the pins looked broken. The repair technician reported the item was worn out in multiple areas, and some of the finishes were rough. Worn out parts is the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded to customer quality. 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
[53975938]
A product investigation was completed: this complaint is confirmed. The returned bending press was received in 9 separate pieces. The dowel pin which secures the handle to the bending housing has sheared in half. Unable to determine a definitive root cause. However, the complaint condition was most likely caused by application of excessive force or cumulative wear on this multiple use bending press. It is not likely that the design of the device contributed to this complaint. A visual inspection under 5x magnification, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. No product design issues or discrepancies were observed. A review of the device history records was unable to be performed since the lot number was unknown. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. The returned bending press is a reusable instrument used to contour/bend plates to better fit patient's anatomy in several systems including the large fragment lcp generic system. The relevant drawing was reviewed during this evaluation. No product design issues or discrepancies were observed. The complaint condition was most likely caused by application of excessive force or cumulative wear on this multiple use bending press. It is not likely that the design of the device contributed to this complaint. 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 | 2520274-2016-13606 |
| MDR Report Key | 5816475 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-22 |
| Date of Report | 2016-07-07 |
| Date Mfgr Received | 2016-09-01 |
| Date Added to Maude | 2016-07-22 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK VORNHEDER |
| 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 | 2016-07-22 |
| Returned To Mfg | 2016-07-21 |
| 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 | 2016-07-22 |