MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-12-05 for BEND/CUT-PLIERS W/NOSE F/LOCK-PI 2 329.143 manufactured by Synthes Gmbh.
[4593487]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported on (b)(6) 2013 during a trauma operation that while the surgeon was bending the matrix mandible (trauma) dcp plate with 4 holes/1. 5mm-thick, a part of the tri radius section at the bender head broke. The operation was able to be completed without a problem. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12082012]
Device was used for treatment, no diagnosis. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07540 |
| MDR Report Key | 3873676 |
| Report Source | 01,05,07 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-11-08 |
| Date of Event | 2013-11-07 |
| Date Mfgr Received | 2013-11-08 |
| Device Manufacturer Date | 2011-07-13 |
| Date Added to Maude | 2014-06-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. RICHARD ROWE |
| 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 |
| Manufacturer City | OBERDORF CH-4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BEND/CUT-PLIERS W/NOSE F/LOCK-PI 2 |
| Product Code | HXP |
| Date Received | 2013-12-05 |
| Catalog Number | 329.143 |
| Lot Number | 7535919 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-05 |