MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DII CONTROLLER; ARTHROSCOPE

Model Number 72200873

Device Problem Connection Problem (2900)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an acl reconstruction procedure, it was not possible to place any handpieces in the ports of the dii controller (neither a nor b).The procedure was completed with a surgical delay greater than 30 minutes using a smith and nephew back-up device.No further complications were reported.

Manufacturer Narrative

H6, health effect - clinical code was updated.H3, h6: the reported device was received for evaluation.A visual inspection found a bent guide key in port a and b.Unable to test ports do to bent guide key.There was a relationship found between the returned device and the reported event.The complaint was confirmed, and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include excessive force, misalignment, or twisting of the connector during connection/disconnection to the control unit receptacle.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 review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.H8, usage of device was corrected.

Event Description

It was reported that, during an acl reconstruction procedure, it was not possible to place any handpieces in the ports of the dii controller (neither a nor b).The procedure was completed with a surgical delay greater than 30 minutes using a smith and nephew back-up device.No further complications were reported.The results of investigation revealed a bent guide key in port a and b.

Manufacturer Narrative

Additional information in d4, serial number.

• Brand Name: DII CONTROLLER
• 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: 15325088
• MDR Text Key: 303632884
• Report Number: 1643264-2022-00308
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 03596010607409
• UDI-Public: 03596010607409
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200873
• Device Catalogue Number: 72200873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1