MAUDE Adverse Event Report: NEWDEAL SAS ACHILLON SYSTEM; N/A

Catalog Number 119700

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

Dhr - lot fntc, involved in this incident was manufactured according to current specifications.No anomaly was found during this review.Failure analysis - no defect was found.Root cause - as no anomaly was found during dhr review and failure analysis, root cause cannot be determined.

Event Description

It was reported that after the product was placed in the hindfoot, the lateral screw did not work (it didn't distracted the inner part of the product) and the product could not be used.The product was in contact with the patient; however, no patient injury reported and the event lead to 20 minutes surgical delay.The procedure was completed with a replacement device.

• Brand Name: ACHILLON SYSTEM
• Type of Device: N/A
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7918280
• MDR Text Key: 122303130
• Report Number: 9615741-2018-00112
• Device Sequence Number: 1
• Product Code: HCF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119700
• Device Lot Number: FNTC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR