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

Model Number	014396
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, when the package of the drill tip guide wire was opened and the rubber protective cap was removed from the rod, a piece of the cap was completely adhered to the rod.The procedure was completed without delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
The reported 014396 2.4mm drill tip guide wire was returned for evaluation.This instrument calls for a foam tube style tip protector.The product was opened but was unable to be used.Customer made attempt to remove the cap.Evaluation confirmed that removal was extremely difficult and left residue behind.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.

• 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: 10181930
• Report Number: 1219602-2020-00943
• Device Sequence Number: 14093386
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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 Expiration Date: 07/18/2024
• Device Model Number: 014396
• Device Catalogue Number: 014396
• Device Lot Number: 2037043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1