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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER

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SYNTHES MONUMENT DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA REAMER Back to Search Results
Catalog Number 314.742
Device Problems Break; Material Fragmentation
Event Date 10/11/2016
Event Type  Malfunction  
Manufacturer Narrative

Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. (b)(6). The subject device has been received and is currently undergoing investigation. The results are pending completion. A device history record review has been requested, the results are pending completion. 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 (b)(4) reported an event in (b)(6) as follows: it was reported that during a revision surgery due to a chronic knee infection not related to synthes devices, the end of the reamer/irrigator/aspirator drive shaft broke interoperatively. No fragments were retained in the patient. There was no reported patient harm due to the event. This report is 1 of 1 for (b)(4).

 
Manufacturer Narrative

Device history records review was completed for part # 314. 742, lot # 7081940. Release to warehouse date: (b)(6) 2013, supplier: (b)(6). 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. 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

Device was used for treatment, not diagnosis. The manufacturing evaluation results are as follows. The evaluation has shows that the hexagon is broken off at the crossover to the shaft. The manufacturing documents were reviewed and no complaint related issues were found. This device was manufactured in may 2013 according to the specification. The relevant dimensions were checked and no deviation from the specification could be detected. The fracture face is homogenous, which indicates material conformity. These findings speak against a manufacturing related issue. Based on the provided information, it is unknown where, when or how the breakage occurred, we are not able to determine the root cause. We can only assume that a mechanical overload did lead to this malfunction if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
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Brand NameDRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer (Section G)
SYNTHES MONUMENT
1051 synthes ave
monument CO 80132
Manufacturer Contact
mark vornheder
1302 wrights lane east
synthes usa
west chester , PA 19380
6107195000
MDR Report Key6064386
Report Number1719045-2016-10793
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number314.742
Device LOT Number7081940
OTHER Device ID Number(01)07611819739192(10)7081940
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/25/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/06/2013
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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