MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAY ELITE PRMIUM II SHLDR ARTHRO SYS; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Catalog Number 72202042

Device Problem Break (1069)

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

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the drill broke inside the femoral tunnel.Fragments were totally removed.It is unknown if there was delay or if a back up device was used.Procedure was successfully completed.No patient injury or other complications were reported.

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 to look at.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.

• Brand Name: TRAY ELITE PRMIUM II SHLDR ARTHRO SYS
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8462388
• MDR Text Key: 140437969
• Report Number: 3003604053-2019-00041
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 03596010621801
• UDI-Public: 03596010621801
• Combination Product (y/n): N
• PMA/PMN Number: K091627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

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: 72202042
• Device Lot Number: 14990002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 03/28/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1