MAUDE Adverse Event Report: NEWDEAL S.A.S DEVICE FOR NAIL FIXATION; PANTA NAIL

Catalog Number 519110ND

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported the compression device jammed when inserted into the device for nail fixation.The surgeon tried wetting the arms and it didn't work.Then he tried using the mallet.It took 15 mins of tapping with the mallet before it slid free.The compression knob would not click on.It delayed the case 15-20 mins.It is reported the device was in contact with the pt; however, there was no pt injury.It was reported revision and/or medical intervention was required.Add'l info received 01/28/2015.There was a delay in the case.But no revision surgery was necessary.

Manufacturer Narrative

Integra has completed their internal investigation on 01/23/2015.The add'l investigation activities included - methods: eval of actual device; review of device history records; review of complaint history.Results: a review of the design specifications and design changes was performed.Review of specifications was done.No significant design change was done on dimensions linked to the assembly between (b)(4).A review of the device history was performed for (b)(4).The manufacturing lot is f52j and it has been manufactured in 04/2013.Check assembly is in compliance with specification.A review of the device history record found no anomalies during the manufacturing period of (b)(4).The manufacturing lot is f7sr and it has been manufactured in 12/2013.Check assembly is in compliance with specification.A review of the device history record found no anomalies during the manufacturing period of (b)(4).The manufacturing lot is f518 and it has been manufactured in 04/2013.No anomaly was found about threaded part.Prior to release, the following frequency determined by probability law applied to incoming inspection, (b)(4) support device (b)(4) is tested for: visual aspect - finishing, laser marking and color points; documentary inspection - raw material and heat treatment certificates, measurements report, label and instruction for use; functional inspection - threaded diameter of nail fixation axis, interaxis, interaxis of lateral tubes and height of the lateral tubes.Interaxis and height of lateral tubes are checked following inspection specifications sp010.Prior to release, following frequency determined by probability law applied to incoming inspection, (b)(6) compression device (b)(4) is tested for: visual aspect - finishing laser marking and color point; documentary inspection - raw material and heat treatment certificates, measurements report, label and instruction for use; measurement inspection - external diameter, holes diameters for compression guides and drilling guides.Prior to release, following frequency determined by probability law applied to incoming inspection, (b)(6) threaded axes are tested for: visual aspect - laser marking; documentary inspection - heat treatment, label and raw material certificates; measurement inspection - boring 6, hollow needle 9, flange 20, flange thickness, and flat surface 12 g 6; functional aspect - assembly with nail fixation axis of support device.A review of the complaint system was performed.This is the nine incident reported to newdeal about difficult insertion of compression device into support device for the past two years.As instruments (b)(4) are reusable instruments and used for insertion of each (b)(6) nail implants surgery, the number of sold (b)(6) nail implants is taken.During the same period, about (b)(4) (b)(6) nail have been sold.The complaint (b)(6).It is the third recorded for lot f52j.(b)(4) items were manufactured for this lot.Lot failure rate is (b)(4).It is the second recorded for lot f7sr.(b)(4) items were manufactured for this lot.Lot failure rate is (b)(4).It is the second recorded for lot f518.(b)(4) items were manufactured for this lot.Lot failure rate is (b)(4).A review of the corrective and preventive action plans was performed.One corrective actions plan (b)(4) was recorded in 09/2012 for difficult assembly between (b)(4).A review of non-conformance records is performed for the last two years.A (b)(4) was initiated in 11/2014, following non-conformance of internal diameter of lateral tubes of support device.The internal diameter was under lower limit of specifications.All parts of manufacturing lot f9xt were returned to our supplier for a rework.Conclusion: the event is unconfirmed.The alignment jig meets inspection requirements.The difficult assembly between support device and compression device was not reproduced.Given the description of the event and the observations made during the investigation, the root cause of difficult assembly cannot be determined.The incident cannot be reproduced during failure analysis.

• Brand Name: DEVICE FOR NAIL FIXATION
• Type of Device: PANTA NAIL
• Manufacturer (Section D): NEWDEAL S.A.S; saint priest 6980 0; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4491352
• MDR Text Key: 5329607
• Report Number: 9615741-2015-00002
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/02/2014

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: 519110ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1