MAUDE Adverse Event Report: NEWDEAL S.A.S. ACHILLON SYSTEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Scarring (2061); Rupture (2208)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

The "injury" (2016) published "subcutaneous achilles tendon rupture: a comparison between open technique and mini-invasive tenorrhaphy with achillon1 suture system".The aim of this retrospective study was to analyze and compare clinical and functional results in patients treated with either the conventional open or minimally invasive suture treatment with the achillon1 system.Methods: a retrospective review of 140 patients was performed; 72 were treated with open tenorrhaphy, 68 with the minimally invasive achillon suture system.Results: with a comparable re-rupture rate, there was a statistically significant reduction in surgical time, incidence of minor complications, time required to return to sport activities and return to work in the minimally invasive group.For achillon: two (2) cases of rerupture - considered as major complication, and two (2) cases of scar adhesion - considered as minor complication.Conclusion: achillon suture system is a reliable tool able to reduce the incidence in soft tissue complications if compared to the classic open tenorrhaphy, while maintaining the strengths and leading to superimposed functional outcomes.The shorter time of surgery and rehabilitation, as well as the lower amount of work days lost, are further advantageous factors in terms of both patient's life quality and social cost.

Manufacturer Narrative

As manufacturing lot number was not provided, no dhr review could be performed.As products were not returned, no failure analysis could be performed.As no dhr review or failure analysis was performed, root cause for re-rupture and scar adhesion cannot be determined.Concerning re-rupture due to non-compliance, postoperative rehabilitation protocol was not followed and brace was removed few days after surgery: this was the reason of re-rupture.

Event Description

N/a.

• Brand Name: ACHILLON SYSTEM
• Type of Device: ACHILLON
• Manufacturer (Section D): NEWDEAL S.A.S.; immeuble sequoiaz; 97 allee alexandre borodine; 69800 saint priest ; FR
• MDR Report Key: 7681055
• MDR Text Key: 113759462
• Report Number: 9615741-2018-00094
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other