MAUDE Adverse Event Report: NEWDEAL SAS CANNULATED DRILL FOR 7.5MM SCREWS; N/A

Catalog Number 119174ND

Device Problem Mechanical Problem (1384)

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

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

No anomaly was observed during the review of the design, manufacturing and quality records.Root cause could not determine.Failure analysis is not possible for the moment as no product was returned.Device identifier : (b)(4).

Event Description

A sales representative reported an event with a cannulated drill for 7.5mm screws (product id (b)(6)) that happened on (b)(6) 2019: the operating room staff tried to drill over the 2.5mm k-wire, but they couldn't drill all the way because they ended up drilling in the k-wire.They checked if the k-wire was bend, but it didn't looked like that was the case.They used a 2.2mm k-wire of their own and that worked and they placed the screw without a problem.No patient injury reported and the event did not lead to surgical delay.

• Brand Name: CANNULATED DRILL FOR 7.5MM SCREWS
• 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: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8386115
• MDR Text Key: 137702451
• Report Number: 9615741-2019-00004
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119174ND
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• 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