MAUDE Adverse Event Report: NEWDEAL SAS QWIX 2 IN 1 - 2.2MM DIA X 65MM LENGTH DRILL; N/A

Catalog Number 159027SND

Device Problem Mechanical Problem (1384)

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

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 physician reported the 1.0mm k-wires get stuck repeatedly in the canula of the 2 in 1 drill.No patient injury was reported.Surgical delay was notified by the surgeon as three minutes which he finds substantial on a surgery of 20 minutes.

Event Description

N/a.

Manufacturer Narrative

Given the description of the event and the observations during documentation review, the root cause cannot be determined as the issue is not confirmed.No anomaly was found during the review of the design specifications, manufacturing and inspections specifications and quality records.No trend is observed.In addition, the inspection of the returned product does not reveal any anomaly and do not confirm the issue.

• Brand Name: QWIX 2 IN 1 - 2.2MM DIA X 65MM LENGTH DRILL
• 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: 11372229
• MDR Text Key: 242464452
• Report Number: 3014334038-2021-00031
• Device Sequence Number: 1
• Product Code: HTW
• 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

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 159027SND
• Device Lot Number: FTRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1