MAUDE Adverse Event Report: NEWDEAL SAS DEPTH GAUGE FOR DIAM 3.5 SCREW; UNI-CP

Catalog Number 219335ND

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As no lot number was provided, no dhr review is performed.Product not returned.Failure analysis could not be performed.As no dhr review and failure analysis could be performed, root cause cannot be determined.

Event Description

It was reported a faulty depth gauge, the product is loose and not working well.No patient contact or injury reported and the event did not lead to surgical delay.

Manufacturer Narrative

Root cause of the issue is damages on the product.No anomaly was found during review of the manufacturing or quality records.No trend was found during the review of the complaint history.Verification on returned device shows products have some traces of use such as scratches and deformation.In addition, the body is not well maintained.Use of the device is possible but can be more difficult for the user.

Event Description

N/a.

• Brand Name: DEPTH GAUGE FOR DIAM 3.5 SCREW
• Type of Device: UNI-CP
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• MDR Report Key: 7855577
• MDR Text Key: 119813985
• Report Number: 9615741-2018-00110
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: FHMQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 02/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1