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

Model Number 014396

Device Problem Melted (1385)

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

Event Date 10/06/2020

Event Type  malfunction  

Event Description

It was reported that during a surgery when the package was opened, the piece of the cap was completely adhered to the rod when it was tried to be removed.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3,h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device was returned with one silicone tip protector attached.The tip protector had been partially peeled off, but was sticking to the rod in multiple locations.It was difficult to remove and left material behind.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A review of the drawing revision history found that the silicone tip protectors were changed to plastic sleeves in (b)(6) 2019.The change was implemented due to customer feedback that the silicone tip protectors were difficult to remove.The complaint was confirmed and the root cause was associated with the environment.Factors that could have contributed to the reported event include overheating in shipping or storage or prolonged higher temperatures.The tip protectors have been updated to plastic in more recent designs.

• 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: 10784700
• MDR Text Key: 214539027
• Report Number: 1219602-2020-01761
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1