MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Catalog Number 72203013

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 01/22/2019

Event Type  malfunction  

Event Description

It was reported that during an arthroscopic sub-acromial decompression surgery, the doctor used the shaver blade and after a few minutes of shaving, he removed the shaver from the surgical site and it was clear that the shaver blade shaft was bent.Then it was noticed that the shaver blade¿s inner blade broke inside the patient, but this was contained inside the outer blade of the shaver blade.So, there were no pieces that came loose from the device.The outcome of the patient is good.A backup device was available to complete the procedure with no significant delay and no patient injuries.

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.(b)(4).

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• 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: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8304510
• MDR Text Key: 135162907
• Report Number: 1219602-2019-00133
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 10/11/2023
• Device Catalogue Number: 72203013
• Device Lot Number: 50764034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• 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