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 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).A device history record (dhr) review was performed for part # 03.503.057, lot # 3053519: (b)(4), manufacturing date: feb 20, 2009.No non conformance reports (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.The device has been 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 the plate cutter broke while cutting a 2.8 mandible plate on (b)(6) 2017 during an unknown procedure.The missing screw hole was the reason for the breakage.No fragments were generated.No patient harm reported.Procedure was successfully completed with no surgical delay.Reportedly there was no other medical intervention required.Concomitant device reported: plate (part # unknown, lot # unknown, quantity 1) this report is for one (1) matrixmandible short cut plate cutter (b)(4).

Manufacturer Narrative

Customer quality (cq) conducted an investigation of the returned device.The visual inspection of the returned shortcut has shown wear marks, scratches and strongly damages on the cutting area of the instrument.The investigation has shown that the complained shortcut is broken in two halves.The cutting edge presents some damages.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.This instrument was manufactured in february 2009 with a lot size of 15 pieces and we are not aware of any other complaint for this article- and lot combination.The measurements of the hardness after the hardening procedure were between 58.25-58.5 hrc also within the specification of 56 +3/0 hrc.The used material was stainless steel cpm t420v as required.Based on these findings we assume that the edges got damaged during previous cuttings and the shortcut finally broke due to high applied mechanical force.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: 6823953
• MDR Text Key: 84342922
• Report Number: 3003875359-2017-10429
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 07611819894426
• UDI-Public: (01)07611819894426(10)3053519
• 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: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• 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: 3053519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2009
• 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