MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL TIP GUIDE WIRE 2.4MM; PASSER

Model Number 014396

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2020

Event Type  malfunction  

Event Description

It was reported that, during set up for a procedure, the guide wire's package was opened and the rubber protective cap removed.It was noticed that a piece of the protective cap was completely adhered to the rod.There was a backup device available.No delay or further complications were noted.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 0143962.4mm gide wire drill tip intended for use in treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.Instruction for use documentation contains precautionary statements and recommendations for proper use of product.The complaint dissatisfaction points to the performance of a protective cap used during packaging vs.The actual guidewire product sold.Root cause was indicated as vendor based; inefficient material curing time.The situation was corrected.Action was taken to purge old stock of the silicone caps and replace them with a different style protector to prevent the issue going forward.Complaint history review for three previous years indicated a similar allegation for the product reported.Batch review was unattainable without a valid lot number reported.The failure drove investigation resulting with a supplier process improvement.No further investigation warranted at this time.Complaint surveillance continues to monitor rate of failure occurrence.

• Brand Name: DRILL TIP GUIDE WIRE 2.4MM
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10273067
• MDR Text Key: 198781562
• Report Number: 1219602-2020-01030
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010374691
• UDI-Public: 03596010374691
• Combination Product (y/n): N
• PMA/PMN Number: K920621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 014396
• Device Catalogue Number: 014396
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1