MAUDE Adverse Event Report: SMITH & NEPHEW ARTHROCARE WAND - STV SUPER TURBO VAC 90; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number A5C4250-01

Device Problem Flaked (1246)

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

Event Date 05/16/2019

Event Type  malfunction  

Event Description

Arthrocare wand (smith & nephew) serial# (b)(4), lot 190370 had potential flaking of adhesive "(loctite)" while in use.Wand was reprocessed by (b)(4).Through investigation, it was reported that adhesive is not bioabsorbable.It is unk whether any material was retained in the pt or was flushed out.Surgeon feels it was not returned.Note - we have had a total of 3 cases with this same situation.Dates of use: (b)(6) 2019.Diagnosis or reason for use: rotator cuff repair.Smith & nephew (b)(4).

• Brand Name: SMITH & NEPHEW ARTHROCARE WAND - STV SUPER TURBO VAC 90
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Manufacturer (Section D)

• MDR Report Key: 8749353
• MDR Text Key: 150155952
• Report Number: MW5087720
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Expiration Date: 04/15/2020
• Device Model Number: A5C4250-01
• Device Catalogue Number: A5C4250-01
• Device Lot Number: 190370
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR