MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REP DYONICS POWER II CONTROL UNIT ARTHROSCOPE

Model Number 72200873S

Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4). The reported device, intended for use in treatment, was received for evaluation. A visual inspection was performed on the product and no issue was observed. There was a relationship found between the returned device and the reported incident. Product failed functional testing with handpiece stall error. Cause of errors is a defective electronic component. The complaint was confirmed and the root cause has been determined to be a defective electronic component. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. A complaint history review concluded this was a repeat issue.

Event Description

It was reported that during set up or inspection for an unknown procedure the port a is not driving the hand piece and the port b is 90 degrees off in the dyonics power ii control unit. The procedure was successfully completed without delay using a back-up device. No patient injury or other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: SVCE REP DYONICS POWER II CONTROL UNIT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11479024
• MDR Text Key: 239692810
• Report Number: 1643264-2021-00993
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 72200873S
• Device Catalogue Number: 72200873S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown