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

Model Number	999904
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005975929-2021-00377
• Device Sequence Number: 14630994
• Product Code: NXT
• UDI-Device Identifier: 03596010504609
• UDI-Public: 03596010504609
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown