MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR VENTING CANNULA 2.3MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 999904

Device Problem Break (1069)

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

Event Date 06/02/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a bhr surgery, a bhr venting cannula 2.3mm broke when trying to pull it out of the femur.The surgeon was able to pull the rest of the cannula out with the ronguer.Surgery was resumed, without any delay, with a back-up device.The patient was not injured as a consequence of this problem.

Manufacturer Narrative

H3, h6: it was reported that during a surgery, a bhr venting cannula 2.3mm broke when trying to pull it out of the femur.The surgeon was able to pull the rest of the cannula out and the surgery was resumed without any delay with a back-up device and the patient was not injured as consequence of this problem.As of today, the device used in treatment has not been returned for evaluation.Without a definitive batch number, a complete review of the historical complaints data cannot be performed for the device.A review of historical complaints data was performed using the part numbers and the reported failure modes to evaluate patterns of repeated failures or defects.Similar complaints have been identified and this will be continuously monitored.As no device batch numbers were provided for investigation, manufacturing record review, device labelling / ifu review could not be performed.If more information is received, this investigation will be reopened.Smith and nephew was not the legal manufacture of this product, there is currently no supplier of venting cannulas therefore no live risk management is available for review.No further actions are required at this time.A review of historic escalation actions related to the products and similar complaint events was performed.Following the review, prior applicable escalation actions were identified and confirmed to reduce associated risks as far as possible.No further escalation actions are required.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the broken cannula.It is noted the pieces were removed.Surgery was performed, without delay, with a s+n back-up device.Patient was not injured as consequence of this problem.Based on the information provided we cannot confirm or further investigate the reported complaint, our investigation remains inconclusive, and a definitive root cause cannot be determined.Specific factors known to contribute to the alleged fault are excessive force, misuse, and general wear and tear.Should the device or additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.

• Brand Name: BHR VENTING CANNULA 2.3MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house, spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14719984
• MDR Text Key: 294878522
• Report Number: 3005975929-2022-00400
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010504609
• UDI-Public: 03596010504609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 999904
• Device Catalogue Number: 999904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention