MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA,OUTFLOW,3MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7204863

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

It was reported that part of an outflow cannula was found on a postoperative x-ray.

Manufacturer Narrative

Additional information received by smith & nephew revealed that we are not the manufacturer of the reported device associated with this complaint.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.Smith & nephew wishes to withdraw this mdr report.

• Brand Name: CANNULA,OUTFLOW,3MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 7154238
• MDR Text Key: 96124141
• Report Number: 1219602-2017-01611
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• PMA/PMN Number: K820367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7204863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1