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 Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

It was reported that during procedure, when the package was opened and the rubber protective cap was removed from the rod, a piece of the cap was completely adhered to the rod.A backup device was available to complete the procedure with no delay or patient injuries.

Manufacturer Narrative

The reported 2.4 mm drill tipped guide wire, intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed, however, a trend of this nature has been observed with this product in the field, prompting a design change which has been implemented to remove the silicone cap and replace it with a tpu sleeve to prevent this issue going forward.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 10311567
• MDR Text Key: 199988951
• Report Number: 1219602-2020-01115
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010374691
• UDI-Public: 03596010374691
• Combination Product (y/n): N
• 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: 08/20/2020

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
• Device Operator: Health Professional
• Device Model Number: 014396
• Device Catalogue Number: 014396
• Device Lot Number: 0238833
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1