MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR STREAMLINE INTRODUCER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 90128285

Device Problem Break (1069)

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

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a tha, after impaction of the cup, a metal rivet was found in the incision.The metal rivet was removed with tweezers.It was determined that the metal rivet might be from the bhr streamline introducer however this is not confirmed.No surgical delay was reported and the procedure was finish with the same device.A post surgery x-ray was performed and not additional metal pieces or debris were found.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: it was reported that during a total hip arthroplasty, following impaction of the cup, metal debris from the bhr streamline introducer may have entered the incision.No patient injury or other complications were reported.As of today, the bhr streamline introducer (part no.90128285, batch no.Unknown) which was used in treatment, and additional information has been requested for this complaint but has not become available.Without a definitive batch number, a complete complaint history review cannot be performed for the bhr streamline introducer.A review of the historical complaints data for the bhr streamline introducer was performed using part numbers and the reported failure modes to evaluate patterns of repeated failures or defects in a timeframe of 12 months prior to the date in which the incident was reported.No other similar complaints have been identified for the part number and the reported failure mode in this timeframe.Without a provided batch number, there is no traceability within sap and the manufacturing records for this device cannot be reviewed.Should more information be provided at a later date, this task will be reopened and completed.However, the released devices would have met manufacturing specifications at the time of production.A risk management review was performed.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.No further actions are required at this time.Without the details of the device involved in this complaint, the specific product labelling and ifus for the devices cannot be reviewed.If this information becomes available at a later time, the task will be reopened and completed.The available medical information was reviewed.It was reported that during a tha, after impaction of the cup, a metal rivet was found in the incision.The metal rivet was removed with tweezers.A post-surgery x-ray was performed, no additional metal pieces or debris were found.Based on the limited information provided the root cause of the reported bhr streamline introducer could not be determined.No patient injuries or adverse consequences were reported.Further, it cannot be concluded that the reported clinical reactions were associated with a mal performance of the instrument.Without the return of the devices used in treatment or additional information we cannot advance the investigation or confirm this complaint; our investigation remains inconclusive, and a definitive root cause cannot be determined.Based on the information provided we are unable to speculate on specific factors known to contribute to the alleged fault.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 STREAMLINE INTRODUCER
• 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: 12561093
• MDR Text Key: 274222745
• Report Number: 3005975929-2021-00461
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 00885556075012
• UDI-Public: 00885556075012
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90128285
• Device Catalogue Number: 90128285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention