MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-12-30 for BENDING PIN FOR 2.4MM LOCKING PLATES 329.922 manufactured by Synthes Gmbh.
[11866954]
According to the manufacturing evaluation, the visual examination noted the second bending pin has a damaged thread. The bending pin is in a used condition and the thread is damaged. The laser etching is readable. Therefore it is not possible to make a statement if it is inside or outside specification. Because of the damaged thread, the measurement and test results for the second bending pin are invalid. Therefore, this complaint is indeterminate from a manufacturing standpoint. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[19924871]
It is reported that during a radius fracture procedure on a (b)(6) canine, surgeon used the bending irons (329. 922) to bend the plate, and one of the irons stripped out, and kept stripping the threads of the plate holes where it was placed. This happened on at least 3 of the holes in the plate ((b)(4)) this plate was no longer usable, and the surgeon discarded the plate. He instead used a 7-hole plate and completed the surgery. Some metal fragments could be seen and remain in the surgical site. This report is for one bending pin for 2. 4mm locking plates. This is report 2 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20407727]
Device used in a veterinary case. No patient information will be provided. A review of the device history records was performed and no complaint related issues were found. The device was received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. The device was received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn
Patient Sequence No: 1, Text Type: N, H10
[28964549]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-05583 |
| MDR Report Key | 3542040 |
| Report Source | 07 |
| Date Received | 2013-12-30 |
| Date of Report | 2013-11-06 |
| Date of Event | 2013-11-06 |
| Date Mfgr Received | 2014-04-25 |
| Device Manufacturer Date | 2013-07-15 |
| Date Added to Maude | 2014-04-02 |
| 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 | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING PIN FOR 2.4MM LOCKING PLATES |
| Product Code | HXP |
| Date Received | 2013-12-30 |
| Returned To Mfg | 2013-12-02 |
| Catalog Number | 329.922 |
| Lot Number | 8490922 |
| 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 GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-30 |