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

Model Number	90128257
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a bhr surgery, the tip of a bhr curved cup introducer broke while impacting.The procedure was resumed, using a s+n back-up device.Patient was not injured as consequence of this problem.It is unknown if a delay occurred due to this event.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H6: it was reported that, during a bhr surgery, the tip of a bhr curved cup introducer broke while impacting.The procedure was resumed, using a s+n back-up device.Patient was not injured as consequence of this problem.It is unknown if a delay occurred due to this event.A review of the complaint history for the bhr curved cup introducer was performed using part and batch numbers for the device during its lifetime, as well as using the part number and failure mode for the prior 12 months to the aware date.Similar but not matching complaints have been identified; this will continue to be monitored via routine post market surveillance trending.A review of historic corrective and preventive actions, preliminary risk assessment, health hazard evaluations, and field actions related to the instrument and similar complaint events was performed.No prior applicable escalation actions were identified for the instrument.A risk management review was performed.No additional risks were identified as result of the reported event.The alleged failure modes and associated risks have been anticipated within the risk file and the anticipated risk level is still adequate.Visual inspection was performed on the returned device, for use in treatment.General wear and tear was noted throughout the body of the device.The x-bar attachment has sheared off, confirming the reported issue.The part and lot numbers are slightly faded but legible.No functional evaluation is needed, as visual inspection confirmed reported failure.Based on the product evaluation of the returned instrument, we can confirm this complaint, yet a definitive root cause could not be determined.Based on the information provided, factors known to contribute to the alleged fault include excessive use or force, making the instrument susceptible to breakage.It should be noted that the bhr surgical technique states ¿examine instruments for wear or damage before use.While rare, intra-operative instrument breakage can occur.Instruments that have experienced excessive use or force may be susceptible to breakage.¿ it is unknown how many cycles the instrument has been through in the 15+ years since manufacture, damage from repeated use can occur.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 CURVED CUP INTRODUCER
• 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: 16527361
• Report Number: 3005975929-2023-00015
• Device Sequence Number: 2645786
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P040033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0703057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 03/29/2023
• 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