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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRIVER,ACL,REDUX-2.4MM ARTHROSCOPE

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SMITH & NEPHEW, INC. DRIVER,ACL,REDUX-2.4MM ARTHROSCOPE Back to Search Results
Catalog Number 014768
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
One 014678 acl redux 2. 4mm driver returned. This instrument is nine years old. It is in good condition with the exception of the hex tip. It has been snapped off from force. There is a 2. 5mm missing portion piece of the hex that was not returned with the product. The product catalogue contains a specific cross reference index for compatible screws from specific suppliers approved for use in conjunction with this product. Ifu says: ¿as with any surgical instrument, careful attention should be exercised to assure that excessive force is not placed on the instrument(s). Applying excessive forces can result in the instrument¿s failure¿. No root cause related to the manufacturing of this device can be established.
 
Event Description
It was reported that the surgeon was removing a screw and the shaft snapped. No patient injuries reported.
 
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Brand NameDRIVER,ACL,REDUX-2.4MM
Type of DeviceARTHROSCOPE
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
MDR Report Key7041219
MDR Text Key118801028
Report Number1219602-2017-01436
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K942079
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number014768
Device Lot Number50262541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2008
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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