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

Model Number 4449

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a clean breakage of the knife retrograde boxed set when used in the operating room.It is unknown whether there was a back up available or delay in the case.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the subject device and the reported incident.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.A review of the instructions for use found: ¿read these instructions completely prior to use.For single use only.Discard any open, unused product.Do not use after the expiration date.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ a review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: KNIFE RETROGRADE BOXED SET
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11164459
• MDR Text Key: 226621909
• Report Number: 1219602-2021-00118
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010129413
• UDI-Public: 03596010129413
• Combination Product (y/n): N
• PMA/PMN Number: K954627
• 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: 03/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4449
• Device Catalogue Number: 4449
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention