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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 07/05/2017
Event Type  malfunction  
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).
 
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).
 
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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 Key6757635
MDR Text Key251468858
Report Number3003875359-2017-10377
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 07/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.503.057
Device Lot Number1975860
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2008
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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