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 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 03.503.057, lot# 1975860.Manufacturing location: (b)(6), manufacturing date: sep 16, 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 device was received and the product evaluation is in progress.No conclusion can be drawn.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017, patient underwent surgery for mandibular reconstruction surgery.During the surgery, the metal part of the matrixmandible short cut plate cutter broke at the root part while the surgeon was cutting a plate to adjust the length of the plate.Procedure was completed successfully.No fragments were generated.There was no surgical delay and no adverse consequence to the patient.Patient outcome is unknown.This report is for one (1) matrixmandible short cut plate cutter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturer investigation and summary investigation were completed on the returned device.1x article 03.503.057 with lot 1975860 forwarded to manufacturing plant for investigation.As received condition of device: the article is in a used condition.The cutter head is broken into two pieces device history record: no ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacturing of the product.Conclusion: all dimensions of the material cross-section, where the cutting head is broken-off, have been measured.These measured dimensions are relevant for the strength of the cutting head, component 60006765.Additionally, the hardness has been tested.All measured characteristics are within specification.No production failure has been found.It has been determined that mechanical overload is the reason for the breakage of the shortcut f/matmand-pl t1.5-2.8 w/rasp.Further, the cutting head, component 60006765, was not sharp anymore due to wear and tear.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.Corrected data: concomitant devices.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

Concomitant devices reported: plate (part number unknown, lot number unknown, quantity 1).

• 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: 6757635
• MDR Text Key: 81519053
• Report Number: 3003875359-2017-10377
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10887587011783
• UDI-Public: (01)10887587011783(10)1975860
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.503.057
• Device Lot Number: 1975860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2008
• 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