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

Catalog Number	7205841S
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10797294
• Report Number: 1643264-2020-01710
• Device Sequence Number: 11510357
• Product Code: HRX
• UDI-Device Identifier: 03596010450005
• UDI-Public: 3596010450005
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K030196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 7205841S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1