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 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that the tip of a bhr venting cannula 2.3mm is broken off.As this was noticed in a non-surgical environment, there was no patient involvement.

Manufacturer Narrative

H3, h6: a bhr venting cannula (part number 999904, batch number 17419) was received for investigation.It was reported that the tip of a bhr venting cannula 2.3mm is broken off.As this was noticed in a non-surgical environment, there was no patient involvement.The instrument is for use in treatment.A visual inspection was performed.Scratches are visible across the length of the device.Laser markings are present, correct, and legible, yet considerably faded.The tip of the device is broken off.The part will not function due to the broken tip.This confirms the reported complaint.A review of the historical complaints data for the bhr venting cannula 2.3mm was performed.Using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe prior 12 months as of the complaint aware date.Other similar complaints were identified to involve this batch and for the part number and the reported failure mode, and this failure will continue to be monitored.The production records were reviewed for the known devices reportedly involved in this incident.All the released devices involved met manufacturing specifications upon release for distribution.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.Based on the limited information provided and product evaluation of the returned instrument, we cannot advance the investigation, our investigation remains inconclusive, and a definitive root cause cannot be determined.Other factors which are known to contribute to the alleged fault are excessive force, misuse, general wear and tear.Based on this investigation, the need for corrective and preventative actions is not indicated.The device cannot be repaired and will be retained.

• 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: 13353119
• MDR Text Key: 284634186
• Report Number: 3005975929-2022-00025
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 999904
• Device Catalogue Number: 999904
• Device Lot Number: 17419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2019
• 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