MAUDE Adverse Event Report: NEWDEAL SAS DRILL DIAM 1.9MM /80MM LENGTH; N/A

Catalog Number 119618

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348)

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 the surgeon used the drill in the hallu-fix travelset.The burr (ref.119 618) didn¿t drill well.The surgeon tried to drill and had to put tremendous force, because of this he hurt himself and had to use a hospital's drill instead of the drill in the hallu-fix set.No patient injury reported and the event lead to 15 minutes surgical delay.Additional information received on december 21, 2017: the surgeon injured his finger.It was a superficial wound.He disinfected his finger and put a bandage.

Manufacturer Narrative

Additional information received january 11, 2018: the quality of the patient¿s bone was good.The surgeon eventually used another 1.9mm drill (one in the hospital) and didn¿t experience any difficulties.Nothing unusual happened.The surgeon followed all steps.Additional information received january 15, 2018: implant references used during surgery hallu c plate: 117 445 & 2.7 snap off screw: 1x 117 014, 2x 117 016, 2x 117 018, 1x 117 024 & k-wire: 115 216, 115 100.The issue happened when the surgeon tried to drill the first proximal (oval) hole in the plate.Since the surgeon hurt himself he removed the drill and used another drill from the hospital to finish the four other holes and the trans-articular screw.Integra has completed their internal investigation on january 26, 2018 results: product not returned so evaluation unable to be performed.However, a visual inspection of (b)(4) parts 119618 batch fmae always in stock was performed on 05 january 2018 and products are compliant with our requirements.Dhr review; no anomaly was found.Complaints history; (b)(4).A capa was opened in 22th august 2016 after several similar incidents.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: (b)(4) recall approved 23 sept 2016.A non-conformance was opened in 23th june 2016: parts of the batches fe58, fhby and fhbz were concerned about hhe recall and were returned to the supplier for a rework.Moreover, a scar was opened also to notify the supplier about the issue with the drill not drilling well.Conclusion: as no anomaly was found during documentary review and visual inspection of the parts in stock, the root cause cannot be determined.

• Brand Name: DRILL DIAM 1.9MM /80MM LENGTH
• 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: 7174935
• MDR Text Key: 96732169
• Report Number: 9615741-2017-00045
• 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: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 119618
• Device Lot Number: FMAE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other