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U.S. Department of Health and Human Services

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

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SYNTHES HAGENDORF MATRIXMANDIBLE SHORT CUT MATRIXMANDIBL INSTRUMENT,CUTTING,ORTHOPAEDIC Back to Search Results
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).
 
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Brand NameMATRIXMANDIBLE SHORT CUT MATRIXMANDIBL
Type of DeviceINSTRUMENT,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 Key6690348
MDR Text Key79732989
Report Number3003875359-2017-10326
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.503.057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2017
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 Unkown

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