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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
Model Number 014396
Device Problem Melted (1385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2020
Event Type  malfunction  
Event 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.
 
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Brand NameDRILL TIP GUIDE WIRE 2.4MM
Type of DevicePASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10784700
MDR Text Key214539027
Report Number1219602-2020-01761
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K920621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number014396
Device Catalogue Number014396
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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