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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 09/27/2017
Event Type  malfunction  
Manufacturer Narrative
A product investigation was performed. This complaint is confirmed. Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken. Visual inspection, device history record (dhr) review and drawing review were performed as part of this investigation. No product design issues or discrepancies were observed. The overall balance of the device looks in a worn condition with signs of wear all over the surface which does not impact functionality. There are some minor dent marks on both the cutting edges of the device which may affect the device's cutting ability to certain extent. The device is broken in such a way that two cutting halves are separated. There are no missing fragments. No new malfunctions were identified as a result of the investigation. A material check or hardness check were not performed at cq as there is no indication that the material or hardness would have contributed to this complaint for this approx. 9 year old reusable instrument breaking. Short-cut plate cutter drawings were reviewed. The item was found to be manufactured per relevant drawing. The design is adequate for its intended use and did not contribute to this complaint condition. Cutter head drawings were reviewed. Thickness of the cutting blade was measured at multiple points and it measured within specification. It was also found that in the following design revisions, the dimensional changes were made for the plate cutter component under design change order (dco) to strengthen this component and material and process changes were made under dco which would contribute towards the improvement of the device design. No definitive root cause could be determined. The re-usable device is approx 9 years old. It was also observed that it is broken at the weakest/thinnest location of the cutting blade. Some minor dent marks on both the cutting edges of the device were observed which may affect the device's cutting ability resulting in more stress on the observed point of breakage for the device. It is possible that the cumulative wear occurred over the period of 9 years combined with the rough handling of the device either during surgery or the sterilization process may have led to the complaint condition. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. There is no harm to the patient. The returned part was determined to be suitable for the intended use when employed and maintained as recommended. 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 not available for reporting. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Dhr review was completed. Manufacturing location: (b)(4), manufacturing date: 10. Dec. 2008. No 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. 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
It was reported that the matrixmandible short cut plate cutter broke in half during an (orif) open reduction internal fixation of the mandible. The patient was prepped and in the room while the surgeon was trimming the excess of a preformed recon plate when the cutter broke. There was a 2-3 second surgical delay to obtain another cutter. The procedure was completed successfully and the patient was reported as stable. Concomitant device reported: plate (quantity 1). 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 Key6962957
MDR Text Key256724033
Report Number3003875359-2017-10525
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.503.057
Device Lot Number3013415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2008
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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