MAUDE Adverse Event Report: SYNTHES MONUMENT BENDING IRON FOR 1.5MM & 2.0MMPLATES

Catalog Number 329.01

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

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).

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• Brand Name: BENDING IRON FOR 1.5MM & 2.0MMPLATES
• Manufacturer (Section D): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3647870
• MDR Text Key: 20711398
• Report Number: 1719045-2014-00120
• Device Sequence Number: 1
• Product Code: HXP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.01
• Device Lot Number: 2035291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1