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	12/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that while impacting the acetabular component during a thr, the bhr curved cup introducer broke and would no longer stay attached to the implant (inside the patient).A smith and nephew back up device was available.No injury to patient or delay reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during a total hip replacement, a bhr curved cup introducer broke.A smith and nephew back up device was available; no patient injury or surgical delay was reported.A bhr curved cup introducer (part no.90128257, batch no.18.232924) was returned for investigation.A review of the historical complaints data for the curved cup introducer was performed using batch numbers to evaluate patterns of repeated failures or defects over the lifetime of the product and 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 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.The production records were reviewed for the devices reportedly involved in this incident.All released devices involved met manufacturing specifications upon release for distribution.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.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.A review of escalation actions related to the product and similar complaint events was performed.Following the review, no prior escalated actions related to this part number and failure mode were identified.No further escalation actions required.Small scratches and minor dents are present across the whole device, consistent with years of surgical use.The wire grip assembly has broken, the weld between the wire grip and threaded rod has fractured.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.Should additional information be received, the complaint will be reopened.Based on this investigation, the need for corrective and preventative actions is not indicated.The device cannot be repaired and will be retained.Adidtional information: d4, h4 b5.
Event or Problem Description
It was reported that while impacting the acetabular component during a thr, the bhr curved cup introducer broke and would no longer stay attached to the implant (inside the patient).A smith and nephew back up device was available.No pieces fell into patient, no injury or delay reported.

• 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: 13226071
• Report Number: 3005975929-2022-00008
• Device Sequence Number: 4127933
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: 18.232924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 03/04/2022; 11/30/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 03/07/2022; 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown