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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONUMENT 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

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MONUMENT 13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR Back to Search Results
Model Number 352.253S
Device Problem Device Operates Differently Than Expected
Event Date 11/01/2017
Event Type  Malfunction  
Manufacturer Narrative

Additional classification code: hrx. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. A review of the device history records has been requested. 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 during a left femur reaming in treatment of a distal tibia non-union, the ria system was utilized for bone grafting material and the drill heads would not advance properly. The surgeon used extreme force in reaming and felt the head was dull so another head was utilized. The same issue occurred and it was difficult to advance through the bone. The surgeon switched out the shaft and then switched back to the original shaft and head to complete the procedure. A 10-15 minute surgical delay was noted due to the difficulty in reaming. No devices broke. There was no information on the initial fracture or any hardware initially implanted. Concomitant devices. Reamer shaft (part# 314. 743, lot# unknown, qty 2). This is report 1 of 2 for (b)(4).

 
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Brand Name13.5MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
Type of DeviceREAMER
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
michael cote
1302 wrights lane east
west chester , PA 19380
6107195000
MDR Report Key7072460
Report Number2939274-2017-50096
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 11/01/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number352.253S
Device Catalogue Number352.253S
Device LOT NumberH118991
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 Received12/01/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/14/2016
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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