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

Catalog Number 119618ND

Device Problems Nonstandard Device (1420); Dull, Blunt (2407); Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2016

Event Type  malfunction  

Event Description

It was reported the drill was not sharp enough.It was later reported the dysfunction was observed during the surgery, after the patient was under anesthesia.There was no patient injury.There was a little increase in surgery time, but it was almost insignificant.The surgery was completed with the same drill.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2017.The investigation activities included: methods: evaluation of device (labeling).Review of device history records.Review of complaint history.Results: pn 119618nd, lot fe58 was manufactured on 8th june 2015 and (b)(4) parts were released.No anomaly was found; all results are compliant with specifications.(b)(4) items were checked during incoming inspection.This is the (b)(4) incident for similar issue after the review complaint records during (b)(4) years.(b)(4) items were sold during this period, drills 119618nd being single use instruments.The global rate failure is evaluated at (b)(4).This is the (b)(4) incident for lot fe58.Product was returned with the recall.A supplier corrective action was assigned to the supplier.Supplier investigation confirmed that it is supplier error in that the approved manufacturing method used for sterile drills was not transferred to non-sterile drills and only 2 lots of non-sterile drills 119618nd are affected.Conclusion: the investigation after several complaints had identified 2 main root causes: a blue print misinterpretation of the mention ¿no relief on point¿ by orchid that caused confusion.The approved manufacturing method used for sterile drills was not transferred properly to non-sterile drills.Indeed, manufacturing of drills 119618 was transferred to the supplier orchid.In a first time, only sterile version was transferred.Non-sterile version was transferred at a second time (due to manufacturing planning).At this time, orchid does not duplicate the manufacturing method from the sterile version to the non-sterile version.Orchid manufacturing technician in charge of the creation of the non-sterile manufacturing method was not aware that similar product already existed in a sterile version.In addition, he did not interpret properly the technical specifications that led to the issue and incorrect manufacturing of the 3 lots (fe58, fhby, and fhbz).In addition, it was found that: internal inspection instruction and training of the inspection operator can be improved.The one-lip design efficiency needs to be verified (questioned by orchid).

• 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
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6227010
• MDR Text Key: 64239966
• Report Number: 9615741-2016-00073
• 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: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• 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: FE58
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1