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

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  

Event Description

It was reported that the surgeon was removing a screw and the shaft snapped.No patient injuries reported.

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.

• Brand Name: DRIVER,ACL,REDUX-2.4MM
• Type of Device: ARTHROSCOPE
• 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 Key: 7041219
• MDR Text Key: 92969150
• Report Number: 1219602-2017-01436
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K942079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 014768
• Device Lot Number: 50262541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1