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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. DRILL TIP GUIDE WIRE 2.4MM PASSER Back to Search Results
Catalog Number 014396
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2019
Event Type  malfunction  
Event 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.
 
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.
 
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Brand NameDRILL TIP GUIDE WIRE 2.4MM
Type of DevicePASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8486955
MDR Text Key141171865
Report Number1219602-2019-00392
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010374691
UDI-Public03596010374691
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K920621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number014396
Device Lot Number2024899
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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