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

Model Number	014396
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10784700
• Report Number: 1219602-2020-01761
• Device Sequence Number: 19867175
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: NOT AVAILABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1