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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA 8.5MM MEDULLARY REAMER HEAD

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SYNTHES USA 8.5MM MEDULLARY REAMER HEAD Back to Search Results
Catalog Number 352.085
Device Problems Break; Material Fragmentation
Event Date 01/30/2016
Event Type  Injury  
Manufacturer Narrative

Device was used for treatment, not diagnosis. (b)(6). Patient dob and weight not provided by reporter. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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 during mid-shaft sub-trochanteric femur fracture for a motor-vehicle accident on (b)(6) 2016, while surgeon was reaming the femur the reamer head got stuck on the bone and disintegrated the tip into the femur to insert a lateral entry femoral nail. It was reported that tip of the reamer head broke and fragments were left inside the patient. Procedure was successfully completed with a small reamer. No surgical delays were reported. Patient/status outcome was reported as "fine. " this report is 1 of 1 for (b)(4).

 
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Brand Name8.5MM MEDULLARY REAMER HEAD
Type of DeviceREAMER
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key5450800
Report Number2520274-2016-11181
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number352.085
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 Received01/30/2016
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

Patient TREATMENT DATA
Date Received: 02/22/2016 Patient Sequence Number: 1
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