MAUDE Adverse Event Report: NEWDEAL SAS DEPTH GAUGE FOR DIAM 3.5 SCREW; N/A

Catalog Number 219335ND

Device Problems Device Operates Differently Than Expected (2913); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

It was reported the length read on the calibration of the depth gauge did not correspond with the length of the measuring tip.There was an estimated difference of around 10 mm.No screw length mistakes were made because of this as it was remarked quickly as this could obviously be seen.The surgeon used another depth gauge from their own to measure the screw length right.It was reported that although the device was in contact with the patient, no patient injury occurred.The event did not lead to an increase of surgery time.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(6) 2017.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: evaluation of returned device; the device is compliant to the requirements.Dhr review; no anomalies associated to the incident were observed.Complaints history; a review of the complaint system was performed for last two years.This is the first incident for similar issue like described in this complaint.Conclusion: the incident is not confirmed.

• Brand Name: DEPTH GAUGE FOR DIAM 3.5 SCREW
• 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: 6219509
• MDR Text Key: 64032666
• Report Number: 9615741-2016-00070
• Device Sequence Number: 1
• Product Code: HTJ
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 219335ND
• Device Lot Number: FCMM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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