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

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Rupture (2208); Injury (2348)

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 journal of bone and joint surgery (2002) published "limited open repair of achilles tendon ruptures".Methods: it was first performed a cadaver study in order to develop an instrument and a technique for a limited open repair and then, using this procedure in conjunction with an early functional rehabilitation protocol, a prospective multicenter study was conducted.This report is on the first eighty-seven patients consecutively treated with the new instrument and followed for an average of twenty-six months (range, eighteen to forty-two months).All patients were assessed clinically and with an enhanced american orthopaedic foot and ankle society (aofas) rating score.In addition, all fifty patients who had been followed for at least twenty-four months were further evaluated with isokinetic dynamometric.Results: four patients were lost to follow-up and one patient died (from a dissecting thoracic aortic aneurysm at eight months postoperatively.According to the family, this patient did not have any difficulty with walking before the time of death), which left eighty-two patients for evaluation.There were no problems with wound-healing, and there were no infections.No patient noted a sensory disturbance in the sural nerve distribution.All patients returned to their previous professional or sporting activities.Two patients had early failure of the achilles tendon repair.Both had been noncompliant with the postoperative regimen and had removed the orthosis.The repairs failed after one patient fell at two weeks and the other fell at three weeks after surgery.Both underwent open surgical repair, which was performed by extending the original incision.A third patient fell while riding a bicycle at twelve weeks after surgery, sustained a rerupture, and also underwent an open repair.All three patients had complete disruption of the original repair.All three new injuries were repaired with an open surgical procedure.Conclusions: this new procedure allows the surgeon to precisely visualize and control the tendon ends while avoiding excessive dissection and disturbance of local vascularity and minimizing nerve and wound-healing problems.Such a technique, along with an early functional rehabilitation program, allowed us to achieve a high rate of successful results with minimal morbidity.

Event Description

N/a.

Manufacturer Narrative

These incidents took place from (b)(6) 1996 through (b)(6) 1999 before the launch on the market of achillon suture system (april 1999).As product involved in these complications was not manufactured by integra, no design / process change review and dhr review could be performed.As products involved in these complications were not manufactured by integra, no failure analysis could be performed.As no failure analysis or dhr review could be performed, root cause cannot be determined.

• 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: 7681062
• MDR Text Key: 113891923
• Report Number: 9615741-2018-00097
• 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: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other