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

Catalog Number 03.503.057

Device Problem Break (1069)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Dhr review was completed.Manufacturing location: (b)(4), manufacturing date: 10.Dec.2008.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 broke in half during an (orif) open reduction internal fixation of the mandible.The patient was prepped and in the room while the surgeon was trimming the excess of a preformed recon plate when the cutter broke.There was a 2-3 second surgical delay to obtain another cutter.The procedure was completed successfully and the patient was reported as stable.Concomitant device reported: plate (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 investigation was performed.This complaint is confirmed.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.Visual inspection, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The overall balance of the device looks in a worn condition with signs of wear all over the surface which does not impact functionality.There are some minor dent marks on both the cutting edges of the device which may affect the device's cutting ability to certain extent.The device is broken in such a way that two cutting halves are separated.There are no missing fragments.No new malfunctions were identified as a result of the investigation.A material check or hardness check were not performed at cq as there is no indication that the material or hardness would have contributed to this complaint for this approx.9 year old reusable instrument breaking.Short-cut plate cutter drawings were reviewed.The item was found to be manufactured per relevant drawing.The design is adequate for its intended use and did not contribute to this complaint condition.Cutter head drawings were reviewed.Thickness of the cutting blade was measured at multiple points and it measured within specification.It was also found that in the following design revisions, the dimensional changes were made for the plate cutter component under design change order (dco) to strengthen this component and material and process changes were made under dco which would contribute towards the improvement of the device design.No definitive root cause could be determined.The re-usable device is approx 9 years old.It was also observed that it is broken at the weakest/thinnest location of the cutting blade.Some minor dent marks on both the cutting edges of the device were observed which may affect the device's cutting ability resulting in more stress on the observed point of breakage for the device.It is possible that the cumulative wear occurred over the period of 9 years combined with the rough handling of the device either during surgery or the sterilization process may have led to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.There is no harm to the patient.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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.

• 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: 6962957
• MDR Text Key: 90696646
• Report Number: 3003875359-2017-10525
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10887587011783
• UDI-Public: (01)10887587011783(10)3013415
• 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,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• 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: 3013415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2008
• 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