MAUDE Adverse Event Report: NEWDEAL SAS MECHE NON CANULEE DIA 1,9; HALLUFIX

Catalog Number 119618ND

Device Problem Dull, Blunt (2407)

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

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

The deice involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported that the hallufix drill was not enough sharp.Product was in contact with the patient; however, no patient injury was reported and the event did not lead to surgical delay.2 of 2 reports: other mfg report number: 9615741-2019-00019.

Manufacturer Narrative

Product was received for evaluation: dhr - no anomalies found.Failure analysis - a visual inspection is done as receipt.Multiple traces of use are observed.No other anomaly is noted.A drilling test is performed on the returned drill with the help of a motor in a saw bone (density 40 pcf ¿ density similar to cortical bone).No issue is observed.A hole (depth 20 mm) is done in few seconds.Root cause - as no anomaly was found during documentary review and failure of the returned part, the issue cannot be duplicated.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6) , director of regulatory programs, office of product evaluation and quality and (b)(6) , assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

Event Description

N/a.

• Brand Name: MECHE NON CANULEE DIA 1,9
• Type of Device: HALLUFIX
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 9261988
• MDR Text Key: 191030907
• Report Number: 9615741-2019-00018
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K083154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119618ND
• Device Lot Number: EDF7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1