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

Catalog Number 03.503.057

Device Problem Break (1069)

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

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(6).Without a lot number the device history records review could not be completed.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that the plate bender broke into two (2) pieces during plate bending (gold plate) during a mandible reconstruction procedure on (b)(6) 2017.No fragments were generated, no surgical delay reported.Procedure was completed, no additional intervention was needed.No reported patient harm.Concomitant part reported: unknown mandible plate, gold (part # unknown, lot # unknown, qty.1).This report is for one (1) matrixmandible short cut plate cutter.This is report 1 of 1 for complaint (b)(4).

• Brand Name: MATRIXMANDIBLE SHORT CUT MATRIXMANDIBL
• 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: 6690348
• MDR Text Key: 79732989
• Report Number: 3003875359-2017-10326
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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