MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE,5.5MM,SER 3000; SAW, POWERED, AND ACCESSORIES

Catalog Number 7206010

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that black fluid was leaking out of the 5.5mm full radius blade and into the patient's joint.A backup was used to complete the procedure.It was noted that the black fluid was removed via suction.Delay was less than 30 minutes and no patient impact was noted.

Manufacturer Narrative

Device investigation narrative - one 5.5 full radius blade was returned for evaluation.Visual assessment showed the device is contaminated with an unidentifiable residue.Examination of the inner and outer blade surfaces showed no evidence of debridement.The condition of the blade eliminates it as the source of the reported contamination.Further investigation is not warranted at this time.Udi: (b)(4).

• Brand Name: FULL RADIUS BLADE,5.5MM,SER 3000
• Type of Device: SAW, POWERED, AND ACCESSORIES
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 5784289
• MDR Text Key: 49906380
• Report Number: 1219602-2016-00368
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2018
• Device Catalogue Number: 7206010
• Device Lot Number: 50595113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2016
• 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