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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES HAGENDORF MATRIXMANDIBLE SHORT CUT PLATE CUTTER INSTRUMENT,CUTTING,ORTHOPAEDIC

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SYNTHES HAGENDORF MATRIXMANDIBLE SHORT CUT PLATE CUTTER INSTRUMENT,CUTTING,ORTHOPAEDIC Back to Search Results
Catalog Number 03.503.057
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2016
Event Type  malfunction  
Manufacturer Narrative
Patient information is not available for reporting. Date of event is unknown. Device is an instrument and is not implanted / explanted. Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Device history records review was completed for part# 03. 503. 057, lot# 1896320. Manufacturing location: (b)(4), manufacturing date: sep 17, 2008. No non conformance reports were generated during production. Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.
 
Event Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2016. During the procedure while cutting a recon plate, the shortcut plate cutter broke/snapped. It was noted that the plate was not seated all the way into the cutter. The surgeon finished the procedure with a back-up device that was readily available. The pieces were easily retrieved without any surgical or medical intervention. There was no surgical time delay reported and the procedure was successfully completed. There was no patient harm. The patient status was reported as fine. Concomitant device reported: plate (part# unknown, lot# unknown, quantity 1). This report is for one (1) matrixmandible short cut plate cutter. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
A product development investigation was performed on the returned device (matrixmandible short cut plate cutter, part # 03. 503. 057, lot # 1896320). The returned plate cutter was confirmed to be broken. The distal cutting surface broken off of the main body of the cutter. The balance of the cutter has surface wear which does not impact functionality. A visual inspection, drawing review and device history record (dhr) review were performed as part of this investigation. The complaint is confirmed. Replication of the complaint condition is not applicable as the device is already broken. The plate cutter is intended for use in cutting plates, when desired, with a thickness of 1. 5 mm to 2. 8 mm. During use, two of these devices are required and function by placing the plate in the slots, aligning the flat surfaces of the devices, and then squeezing the cutters together to rotate them and cut the plate. This information is provided per the matrixmandible plating system technique guide. The following drawings were reviewed during investigation: short-cut plate cutter, cutter head. Dimensional changes to the cutting feature were made to improve the strength of the cutter head. The drawing has been updated for the cutter head in april, 2010. Thus, since the device was manufactured prior to the design change, the device design likely contributed to the complaint condition. The current design was determined to be suitable for the intended use when employed and maintained as recommended. Therefore, from a design perspective this complaint is valid but has already been addressed. 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.
 
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Brand NameMATRIXMANDIBLE SHORT CUT PLATE CUTTER
Type of DeviceINSTRUMENT,CUTTING,ORTHOPAEDIC
Manufacturer (Section D)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer (Section G)
SYNTHES HAGENDORF
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6229025
MDR Text Key64058582
Report Number3003875359-2017-10009
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.503.057
Device Lot Number1896320
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/06/2017 Patient Sequence Number: 1
Treatment
ONE (1) UNKNOWN PLATE
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