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

Catalog Number 219335ND

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

2 of 2 reports.Other mfg report number: 9615741-2021-00003.A physician reported the depth gauge did not measure correctly in the tibiaxys set in consignment.Reading is 20 but it must be more.The surgeon used the depth gauge to know the screw to choose.At the end of the surgery, she checked with fluoroscopy and discovered that the screws used were too short.Consequently 5 screw need to be replace which increased the surgery time approximatively 30 minutes.The patient has no consequence.Devices seems not dame or torn, they are just too short.

Event Description

N/a.

Manufacturer Narrative

Complaint sample was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.After review of the pictures provided and a comparison with technical specifications and quality alert, it is confirmed that the metallic tip of depth gauge p/n 159400nd was switched with the depth gauge p/n 219335nd.As the products were in a consignment set at the customer, the switch had to happen during decontamination/cleaning steps between surgeries.The root cause of this incident is a user error.The metallic tips of the depth gauges were switched and led to incorrect measurements for the screws.

• 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
• MDR Report Key: 11499137
• MDR Text Key: 240317043
• Report Number: 9615741-2021-00004
• 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: 06/08/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 219335ND
• Device Lot Number: FL16
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1