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

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.

• Brand Name: ACN
• Type of Device: ACN NAIL ATTACHMENT ROD
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 7832270
• MDR Text Key: 119157824
• Report Number: 2183449-2018-00022
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 177110
• Device Lot Number: V1354034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2018
• Distributor Facility Aware Date: 08/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR