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

Catalog Number PANTAIMP

Device Problems Unstable (1667); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/23/2014

Event Type  malfunction  

Event Description

It was reported that the surgeon performed a revision surgery (of an unk device).During surgery the surgeon discovered a shortage of the panta screws and the size 10 panta nail.The surgeon had to over ream one bigger size in a small bone with the risk of penetrating the tibial cortex and he had to cut the screws.Additional info received on (b)(6) 2014.The patient is (b)(6) with multi deformities due to a "renal problem." her left hind foot was grossly unstable and was previously operated on in another facility with an 'unk' nail.She presented to the surgeon with an exposed screw and a failed fusion.The surgeon removed the hardware of the previously performed hind foot fusion and used a panta nail and the head of the patient femur as allograft.Due to the shortage of the devices reported by the surgeon, he had to cut the screws and the surgery time was increased about one hour.There was no injury or adverse consequence to the patient reported.The surgeon reported that he had 'enough experience with panta nail and was able to manage the problem.'.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.

• Brand Name: PANTA IMPLANT SET
• Type of Device: NA
• Manufacturer (Section D): NEWDEAL S.A.; saint priest 6980 0; FR 69800
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3994724
• MDR Text Key: 4820793
• Report Number: 9615741-2014-00029
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K091788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2014

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: PANTAIMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 06/11/2014
• 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
• Treatment: PANTA NAIL SIZE 10; PANTA SCREWS
• Patient Age: 27 YR