MAUDE Adverse Event Report: NEWDEAL SAS SCREWDRIVER TORX T7; N/A

Catalog Number 219127ND

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2020

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

A facility reported that on (b)(6) 2020 the screwdriver broke during removal of the hallulock screws & endcap.No patient injury reported and the event led to 10 minutes surgical delay.

Manufacturer Narrative

Device identifier: (b)(4).The root cause cannot be determined at this time.Results of the documentary investigation does not reveal any issue about the design, the manufacturing, during the use.No trend for this kind of incident is observed.Associated risk is correctly evaluated.Product is currently not returned to integra so no failure analysis is possible at this time.Following previous similar incidents, it was observed that the required loosening torque during hallu lock removal is more important cause of the bone growth around the implants and can reach the mechanical limit of the raw material.Furthermore, due to the size of the associated screws, the dimensions of the tip of screwdriver 219127nd are very tiny and per consequence fragile when it used repeatedly and / or with important torque.For removal procedure, a dedicated removal kit is available with 2 screwdrivers p/n 219127nd that are checked between each removal surgery in order to limit the observed risks.

Event Description

N/a.

Manufacturer Narrative

Screwdriver was returned for evaluation: dhr - no anomalies.Failure analysis / root cause - it is observed during visual inspection that tip is broken and twisted.As the tip is twisted, it means that a plastic deformation of the tip occurred prior to the breakage and is due to the application of a stress superior to the mechanical resistance of the device.

• Brand Name: SCREWDRIVER TORX T7
• 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: 11073569
• MDR Text Key: 228277753
• Report Number: 9615741-2020-00019
• Device Sequence Number: 1
• Product Code: HXX
• 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,Followup
• Report Date: 10/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 219127ND
• Device Lot Number: FTL7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/25/2020
• Supplement Dates Manufacturer Received: 01/25/2021; 09/27/2021
• Supplement Dates FDA Received: 02/10/2021; 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1