MAUDE Adverse Event Report: NEWDEAL SAS MECHE NON CANULEE DIA 1,9 X L.; N/A

Catalog Number 119618SND

Device Problems Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that during the use of drill in the loan set hallufix, the surgeon had many difficulties to drill the first dorsal cortical with this drill.When he managed to drill, he was hurt by the drill.The drill did not work as expected.No patient injury reported and the event lead to 10 minutes surgical delay.Additional information received on (b)(6) 2017: "the drill passed through the 2 pair of gloves of the surgeon and stung the finger.Surgeon had a red point on his finger.He had changed the gloves and continued to do the surgery.The drill has been used on the patient when the surgeon was stung.He has probably done antiseptic bath after.The surgeon is ok.".

Manufacturer Narrative

Additional information received on january 11, 2018: no particular issue during surgery.Normal quality of bone for the patient.They finished the surgery with the drill dedicated to staple uniclip in the forefoot 2 set and it works without any issue.The dorsal cortical was drilled normally.Additional information received on january 12, 2018: the implant used for the surgery was (b)(4).The issue happened at the first drilling step for the first oblong hole on metatarsus part.Integra has completed their internal investigation on january 26, 2018: results: evaluation of returned device: diameter 1.9 mm, sharpening of the edge, visual aspect and angle of the flute have been inspected.No anomaly was found.Dhr review; a review of the design specifications and design change was performed the specifications concerning the machining of the drill are established in the drawing plan (b)(4): raw material, finishing, heat treatment, number of lips, effective cutting angle, helix angle and external diameter are clearly specified.Due to a capa, a design change was initiated to update the technical specifications for the manufacturing of the drills to avoid any misunderstanding which can cause lack of machining.The manufacturing of drills of the batch fd25 was performed before the implementation of new specifications related to this design change.However, sterile drills were not impacted by manufacturing mistake which has led to capa and hhe recall.Moreover, performance of drills has been evaluated throughout tests realized by supplier and surgeon: results are compliant with the requirements.In conclusion, design specifications concerned are clearly specified and efficiency of drills has been confirmed.Complaints history; this is the fifth incident for similar issue after the review complaint records during last two years.(b)(4) items were sold during this period, drills (b)(4) being single use instruments.(b)(4).A capa number was opened in 22th august 2016 after several similar incidents.The root cause was a misunderstanding of the blueprint during the industrialization phase of non-sterile drills.Here are the actions realized: review of the manufacturing specifications by the supplier.Test of design¿s efficiency.Update of the technical drawing.Review internal inspection.- regulatory actions following hhe conclusion: hhe recall (only non-sterile products) approved 23 sept 2016.A review of non-conformance records is performed for last two years.A nc was opened in 23th june 2016: parts 119 618nd of the batches fe58, fhby and fhbz were concerned about hhe recall and were returned to supplier for a rework.Parts 119618snd of the batch fd25, present in stock were visually inspected: they were compliant with our requirements.Moreover, a scar was opened also to notify the supplier about the issue with the drill not drilling well.A review of deviation records is performed.No concession that could be linked to ineffectiveness of drills.Conclusion: as no anomaly was found during documentary review and quality inspection of concerned product, root cause cannot be determined.

• Brand Name: MECHE NON CANULEE DIA 1,9 X L.
• Type of Device: N/A
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 7137812
• MDR Text Key: 95501395
• Report Number: 9615741-2017-00044
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 119618SND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other