MAUDE Adverse Event Report: NEWDEAL S.A. IPP-ON IMPLANT STERILE

Catalog Number 230001SND

Device Problem Mechanics Altered (2984)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported at the end of a hammertoe foot surgery, the proximal barbs of the ipp-on implant did not achieve solid cortical contact; therefore the implant would not remain anchored within the pt's medullary canal.The implant was removed and k-wire used by surgeon for joint fusion.Surgery was delayed by 15 minutes due to this issue.There was no adverse consequence or injury to the pt reported to date.

Manufacturer Narrative

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

• Brand Name: IPP-ON IMPLANT STERILE
• 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: 3804618
• MDR Text Key: 4365660
• Report Number: 9615741-2014-00006
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103623
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 230001SND
• Device Lot Number: F7Z3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR