MAUDE Adverse Event Report: NEWDEAL SAS SCREW FOR COMPRESSION FORECEPS DIA.4XL40; N/A

Catalog Number 159740ND

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/09/2016

Event Type  malfunction  

Event Description

It was reported an instrument was implanted by the surgeon.¿the customer confirmed to the customer service representative that the instrument was implanted and did not seem to understand what the issue is.¿ according to integra kitting department, this instrument is not intended for implantation.It was reported no patient injury is alleged.The instrument remains in the patient.

Manufacturer Narrative

Integra completed its internal investigation dec 26, 2016.The investigation included: method: review of device history records.Review of complaint management database for similar complaints.Results: dhr for lot f41l reviewed and no anomalies associated to the incident were observed.The lot was manufactured in july 2012.A review of the complaint system was performed for last (b)(6) years.This is the first incident for similar issue like described in this complaint.(b)(4) tibaxys compression screws ((b)(4)) were sold during last (b)(6) years.The rate failure is rated at (b)(4)%.This is the first incident for the lot f41l.Conclusion: the function of the compression screw is defined in the surgical technique used by the surgeon.A surgical technique is delivered with the tibiaxys system.The surgeon must follow the different steps for the surgery.The incident can be explained by an error during the surgery from the team care.

• Brand Name: SCREW FOR COMPRESSION FORECEPS DIA.4XL40
• Type of Device: N/A
• 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: 6193024
• MDR Text Key: 63321260
• Report Number: 9615741-2016-00067
• Device Sequence Number: 1
• Product Code: HWD
• 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,foreig
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 159740ND
• Device Lot Number: F41L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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