MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNIFE ,RETROGRADE,BOXED SET ARTHROSCOPE

Catalog Number 4449

Device Problems Material Discolored (1170); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/15/2019

Event Type  malfunction  

Event Description

It was reported that during a carpal tunnel release procedure, the blade was emitting metallic colored resin after inserting in to defect and cutting tissue. There was resin left behind in the patient tissue. A backup device was available, but there was no need to used it. No revision surgery is planned due to the event. There was a delay of less than 29 minutes to identify the material. The devices involved were used on the same patient. No reported negative outcome to dates.

Manufacturer Narrative

One ectra retrograde knife returned. The complaint stated: ¿the blades would emit a metallic-colored resin after inserting in to defect and cutting tissue. ¿ the knife was evaluated and found to have a dry, fine, black substance on the surface of the blade. Primarily in the distal area. Evaluation was assigned to engineering. Initial review confirmed that substance was present. Samples were wiped onto paper and isolated to be sent out for lab analysis. Per engineering: ¿based on the detailed development of the safety limits, cleaning process validation, and operator training established for the manufacturing of ectra knives, the impact of the identified contaminant and its overall risk are deemed low. ¿ elements found were determined to be regarded as safe.

• Brand Name: KNIFE ,RETROGRADE,BOXED SET
• 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 ; 5123585706
• MDR Report Key: 8308809
• MDR Text Key: 135149606
• Report Number: 1219602-2019-00147
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 4449
• Device Lot Number: 50681690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial