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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 Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2020
Event Type  malfunction  
Event 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.
 
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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
william
austin, TX 78735
5123913905
MDR Report Key10181930
MDR Text Key196081757
Report Number1219602-2020-00943
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number014396
Device Catalogue Number014396
Device Lot Number2037043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2019
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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