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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL ACN ACN NAIL ATTACHMENT ROD

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ORTHOFIX SRL ACN ACN NAIL ATTACHMENT ROD Back to Search Results
Model Number 177110
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Event Description
Information provided states that during a tibia-talo-calcaneal fusion, the surgeon kept missing the holes in the nail. Surgeon tried to free hand the screw with no success. Dr removed the jig assembly and noticed that the nail attachment rod was crossthreaded. The surgeon was unable to complete the proposed surgery which resulted in a delay in the case. Surgery was completed successfully with alternate product.
 
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Brand NameACN
Type of DeviceACN NAIL ATTACHMENT ROD
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni 9
bussolengo, verona 37012
IT 37012
MDR Report Key7832270
MDR Text Key119157824
Report Number2183449-2018-00022
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number177110
Device Lot NumberV1354034
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/29/2018
Distributor Facility Aware Date08/02/2018
Event Location Hospital
Date Report to Manufacturer08/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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