MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-02-26 for BENDING IRON FOR 1.5MM & 2.0MMPLATES 329.01 manufactured by Synthes Monument.
[20711398]
It was reported that the plate bender broke during surgery. The surgeon was repairing a fracture and while bending the patients plate, the device broke at the tip where the device contours the plate. The patient is a canine patient and there was no patient issue as a result of this event. The procedure was successfully completed. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21113001]
Device was used for treatment, not diagnosis. Device used in a veterinary case. No patient information will be reported. Device is an instrument. Mfr date? 11/19/2002, 12/11/2002. Subject device has been received and is currently in the evaluation process. Investigation is ongoing and no conclusion could be drawn. The manufacturing documents have been reviewed and no complaint related issues were found. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[28715894]
The manufacturing evaluation reveals the part returned for inspection with worn edges. The complaint conditions of the broken tip occurred due to an unknown cause. Discoloration located in the break area and possible oxidation stains. The part initially conformed to all requirements and was inspected/conformed to the synthes incoming final inspection sheet. Based on the evaluation performed and the unknown cause, this complaint is deemed invalid from a manufacturing position.
Patient Sequence No: 1, Text Type: N, H10
[32476833]
According to the product development evaluation, after reviewing the related product drawings, complaint history and risk analysis, the complaint is determined to be indeterminate from a design perspective. It is likely that the bending iron was used on a plate for which it was not designed. The difference in plate thickness could have led to a mechanical overload situation as the force required to bend the plate exceeds the designed limits of the bending iron. Without more information as to which plate was being bent when the device failed, it is impossible to determine whether the bending iron performed as intended. Therefore the complaint is indeterminate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2014-00120 |
| MDR Report Key | 3647870 |
| Report Source | 05,07 |
| Date Received | 2014-02-26 |
| Date of Report | 2014-01-29 |
| Date of Event | 2014-01-23 |
| Date Mfgr Received | 2014-05-23 |
| Device Manufacturer Date | 2002-11-19 |
| Date Added to Maude | 2014-05-12 |
| 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 | 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 MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING IRON FOR 1.5MM & 2.0MMPLATES |
| Product Code | HXP |
| Date Received | 2014-02-26 |
| Returned To Mfg | 2014-02-05 |
| Catalog Number | 329.01 |
| Lot Number | 2035291 |
| 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 MONUMENT |
| Manufacturer Address | 1101 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-26 |