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U.S. Department of Health and Human Services

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

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SYNTHES HAGENDORF MATRIXMANDIBLE SHORT CUT PLATE CUTTER 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 08/02/2017
Event Type  malfunction  
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.
 
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).
 
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Brand NameMATRIXMANDIBLE SHORT CUT PLATE CUTTER
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 Key6823953
MDR Text Key256709618
Report Number3003875359-2017-10429
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.503.057
Device Lot Number3053519
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2009
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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