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

Model Number 90128257

Device Problem Break (1069)

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

Event Date 09/22/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: case- (b)(4).

Event Description

It was reported that, during a thr surgery, one bhr curved cup introducer broke.Surgery/treatment was resumed, without any delay, with a back-up device.No health consequences were reported.

Manufacturer Narrative

H3, h6: it was reported that during a total hip replacement surgery, the bhr cup introducer broke.No surgical delay or patient harm was reported.A bhr cup introducer (part no.90128257, batch no.S0710151) which was used in treatment was returned for investigation.A review of the historical complaints data for the bhr 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.A similar complaint has been 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.A visual inspection was performed.Marks, scratches, and dents were visible across the whole device, consistent with years of surgical use.Strike cap shows evidence of impact damage.Part of wire grip assembly adjacent to the thumb wheel has snapped so the device no longer functions.This confirms the reported complaint.Laser markings were present, correct, and legible although significantly faded.A functional evaluation was not performed as the instrument was confirmed to be broken/non-functional during visual inspection.This device is a reusable instrument that can be exposed to numerous surgeries, it is unknown how many cycles this instrument has been through in its 14+ years life; damage from repeated use can occur.Due to the age of the instrument reportedly involved in this incident and its reported failure, a dhr review was not performed.However, the released instrument involved would have met manufacturing specifications at the time of production (around 2007).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.Based on the information provided and product evaluation of the returned instrument, also taking into account the age of the instrument (13+ years), a probable root cause of the reported failure is the device reaching the end of its useful life.If additional information is received, this case 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.

• Brand Name: BHR CURVED CUP 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; austin, TX 78735 ; 5123913905
• MDR Report Key: 12582908
• MDR Text Key: 274945272
• Report Number: 3005975929-2021-00467
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0710151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• 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: Reuse
• Patient Sequence Number: 1