MAUDE Adverse Event Report: NEWDEAL S.A.S. PANTA XL IMPLANT SET

Catalog Number PANTA-XL

Device Problem Mechanics Altered (2984)

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

Event Date 03/25/2014

Event Type  malfunction  

Event Description

It was reported during a tibio-talar-calcaneus arthrodesis surgery the calcaneal screws went in fine.The compression rods were not used per surgeon discretion.Instead, the surgeon directly inserted the tibia screws and compression was reportedly achieved manually.The surgeon inserted the tibia guides any they didn't line up in the jig.(product id) (b)(4)).There was enough movement in the jig that the compression system wheel was turned slightly to get the tibia guide in.Once the tibia guides were in, additional alignment was required for the tibia bits to cross the (b)(6) rod.On x-ray post operatively the screws were aligned.Surgery was delayed by a few minutes due to this issue.There was no reported adverse consequence to the patient.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: PANTA XL IMPLANT SET
• Type of Device: NA
• Manufacturer (Section D): NEWDEAL S.A.S.; saint priest 6980 0; FR 69800
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3871650
• MDR Text Key: 4592446
• Report Number: 9615741-2014-00015
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PANTA-XL
• Device Lot Number: 009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1