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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA REAMER

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SYNTHES USA REAMER Back to Search Results
Device Problems Fitting Problem; Mechanical Jam
Event Date 05/13/2016
Event Type  Malfunction  
Manufacturer Narrative

Device is an instrument and is not implanted or explanted. Per facility, the complainant parts were discarded and are no longer available for evaluation. Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. 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 a reaming head and reaming tube assembly could not be disconnected from a reamer/irrigation/aspirator (ria) shaft following the completion of an unknown surgical procedure on (b)(6) 2016. The issue was discovered post-operatively. The procedure itself was completed successfully without any delay or patient harm. This report is for one (1) unknown reamer head. This report is 2 of 3 for com-(b)(4).

 
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Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES USA
Manufacturer Contact
terry callahan
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5684976
Report Number2520274-2016-12903
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
OTHER Device ID NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2016
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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