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

Catalog Number 03.503.057

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.A device history record review was conducted for part # 03.503.057, lot # 3102292: manufacturing site: (b)(4), manufacturing date: 25-mar-2009: no non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product development investigation: one matrixmandible short cut plate cutter (part number 03.503.057, lot number 3102292) was received with the complaint category of ¿does not/will not function: fell apart.¿ a device history record (dhr) review, visual inspection, and drawing review were performed as part of this investigation.The complaint condition is confirmed.However, it was noted that the received condition differs slightly from the reported condition in that the device did not just fall apart but is actually broken.The plate cutter was received with the distal cutting surface broken off of the main body of the cutter.The plate cutter is intended for use in cutting plates.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 plate cutter was received with the distal cutting surface broken off of the main body of the cutter.The break is approximately parallel to the cutting surface and through the location of the distal holding pin.The distal holding pin is still retained in the assembly.The cutting surfaces show dents and rolled edges.The balance of the device shows surface scratches and wears consistent with use and is otherwise in working condition.Thus, the complaint condition is confirmed but cannot be replicated as the device is already broken.A review of the current design drawing / manufactured revision for the top level assembly and the cutter head component was performed.Dimensional changes to the cutting feature were made to improve the strength of the cutter head to address this issue.The dco updated the drawing 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.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 the matrixmandible short cut plate cutter fell apart while cutting a plate for a sternal plating procedure.This happened at the back table and not near the sterile field.Another plate cutter was available to use, and the surgery was completed successfully.There were no reported fragments generated, no reported surgical delay, and no reported harm to the patient.During manufacturer investigation process it was identified that the returned device (matrixmandible short cut plate cutter) did not just fall apart but is actually broken.The plate cutter was received with the distal cutting surface broken off of the main body of the cutter.This condition was reassessed and determined to be reportable on december 15, 2016.Concomitant device reported: one sternal plate (unknown part #, unknown lot #, quantity 1).This is report 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE SHORT CUT PLATE CUTTER
• Type of Device: INSTRUMENT,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 Key: 6192814
• MDR Text Key: 62976342
• Report Number: 3003875359-2016-10654
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10887587011783
• UDI-Public: (01)10887587011783(10)3102292
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.057
• Device Lot Number: 3102292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) UNKNOWN STERNAL PLATE
• Patient Age: 37 YR