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

Model Number	014396
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10273067
• Report Number: 1219602-2020-01030
• Device Sequence Number: 3399066
• Product Code: HWQ
• UDI-Device Identifier: 03596010374691
• UDI-Public: 03596010374691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K920621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: 014396
• Device Catalogue Number: 014396
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 08/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1