MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP CONTROL UNIT ASSEMBLY; ARTHROSCOPE

Catalog Number 7205841S

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

It was reported that the control unit was not detecting the handpiece, footswitch was detected but the handpiece had an error.It is unknown if the event happened during a procedure, if there was a delay or backup device available.No further complications 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, intended for use 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 a relationship found between the subject device and the reported incident.A review of the customer provided images showed a control unit showing an error.The device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.The complaint was confirmed and the root cause has been associated with an electronic component failure.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a low or dead battery voltage for the memory chip or a shorted out pcb.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.A complaint history review concluded this was a repeat issue.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: SERVICE REP CONTROL UNIT ASSEMBLY
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10797294
• MDR Text Key: 215093121
• Report Number: 1643264-2020-01710
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010450005
• UDI-Public: 3596010450005
• Combination Product (y/n): N
• PMA/PMN Number: K030196
• 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: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7205841S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1