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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER

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SYNTHES USA FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK REAMER Back to Search Results
Catalog Number 351.16J
Device Problem Device Operates Differently Than Expected
Event Date 08/07/2015
Event Type  Malfunction  
Manufacturer Narrative

Patient information is not available for reporting. Device is an instrument and is not implanted or explanted. Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the service history record review could not be completed. Device 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 mechanism for a flexible shaft connector for use with (b)(6), which consisted of a spring, pin, bolt, and screw, came apart and could not be put back together during a retrograde femoral nail procedure on (b)(6) 2015. Another part from another set was available for use. No patient harm or surgical delay reported. This report is 1 of 1 for com-(b)(4).

 
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Brand NameFLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES USA
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5024357
Report Number2520274-2015-15411
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/07/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number351.16J
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 Received08/07/2015
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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