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

Catalog Number	014396
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the tip of the device was broken.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported 2.4mm drill tip guide wire, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product has not been returned and the pertinent clinical details have not been provided.From the information provided, the guide wire tip broke in the patient and was removed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the instrument can result in failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during procedure, the tip of the device was broken into the patient and pieces were removed.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 2.4mm drill tip guide wire was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.The distal end/drill tip has broken off and was not returned for examination.The shaft is bowed and is scored in a circular manner at various locations along its length.The condition of the device indicates it was likely bent during use causing excessive forces to be applied during drilling.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8486955
• Report Number: 1219602-2019-00392
• Device Sequence Number: 1576607
• Product Code: HWQ
• UDI-Device Identifier: 03596010374691
• UDI-Public: 03596010374691
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K920621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2019

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: 12/01/2023
• Device Catalogue Number: 014396
• Device Lot Number: 2024899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 08/30/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/06/2019; 09/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1