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	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a thr, the central thread of one (1) bhr curved cup introducer snapped upon impaction.There was no delay and patient was not harmed as a consequence of this issue.
Additional Manufacturer Narrative
It was reported that, during a thr, the central thread of a bhr curved cup introducer snapped upon impaction.There was no delay and patient was not harmed as a consequence of this issue.As of today, the instrument which was used in treatment, has not been returned for evaluation.A review of the historical complaints data for the bhr curved introducer was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product.And using part numbers to evaluate patterns of repeated failures or defects in a timeframe 12 months prior to the date in which the incident was reported.Other similar complaints were identified to involve this batch.Other similar complaints have been identified for the part number and the reported failure mode in this timeframe, and this failure will continue to be monitored.In the absence of the actual instrument, the production records were reviewed for the devices reportedly involved in this incident.The goods inwards inspection for a portion of this batch is not available.The record is incomplete and cannot be regenerated.However, all supporting documents confirm that this was an acceptable product when released.Corrective actions have already been raised issues around missing paperwork.The instruments were produced before corrective actions were implemented.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.A review of historic quality escalation actions related to the products and similar complaint events was performed.Following the review, no prior applicable escalation actions were identified.Based on the information provided our investigation remains inconclusive and a definitive root cause cannot be determined.A specific factor known to contribute to the alleged fault is excessive force used during surgery whilst impacting the acetabular cup.If the instrument or additional information becomes available in the future, this case will be reopened.Based on this investigation the need for corrective and preventative action is not indicated.

• 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: 16372806
• Report Number: 3005975929-2023-00010
• Device Sequence Number: 15180282
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2023

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: S0811053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2009
• 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