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 08/04/2021

Event Type  malfunction  

Event Description

It was reported that a bhr venting cannula 2.3mm was found to be broken.As this happened during a field inspection, there is no patient involved.

Manufacturer Narrative

H3, h6: a bhr venting cannula 2.3 mm was received for inspection (part number 999904, batch 1675).It was reported that during an office inspection, the device tip was found to be broken/ snapped off from the device.The broken fragment of the device was not returned.There was no patient involvement.This device is for use in treatment.A review of the complaint history for the bhr venting cannula was performed using batch numbers in search of similar recurring reports for the device.No other similar complaints have been identified for the venting cannula.A review of the historical complaint data for the device was performed using related reported failures and the part number for the prior 12 months from the complaint aware date.One other similar complaint was identified, this will be continuously monitored.Due to the age of the instrument, the production records for this device were unavailable.The released instrument involved would have met manufacturing specifications at the time of production.A visual inspection was performed on the returned device.General wear and tear was noticed across the full length of the device.It was seen that the device was snapped 74.43mm from the tip.Significant wear was observed on the device head.Laser markings were faded but correct and legible.The device is broken and non functional, this confirms the alleged failure mode.No functional evaluation has been performed as the possible failure was confirmed through visual inspection.Based on the available information and returned instrument a probable cause of the broken cannula may be unintentional misuse of the device due to excessive force.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.The instrument will be retained at aurora.

• 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: 12336449
• MDR Text Key: 267067861
• Report Number: 3005975929-2021-00377
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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: 1675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2021
• 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?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1