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

Model Number 900001

Device Problem Break (1069)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during set up or inspection for a thr, the spring inside of the handle of the bhr hi perf cup introducer was broken and the item was not working properly.A back-up device was available.No surgical delay was reported.No patient complications were reported.

Manufacturer Narrative

H3, h6: a bhr cup introducer was received for inspection (part number 900001, batch s0703002).It was reported that during set up or inspection for a thr, the spring inside of the handle of the device was broken and the item was not working properly.A back-up device was available.No surgical delay or patient complications were reported.The device is used in treatment.A review of the complaint history for the bhr cup introducer was performed using batch numbers in search of similar recurring reports for the device.Other similar complaints have been identified for the bhr cup introducer.This will be continue to be monitored.A review of the historical complaint data for the device was performed using related reported failures and the part number for the prior 12 months from the complaint aware date.One other similar complaint was identified, this will continue to be monitored.Due to the age of the instrument, the production records for this device were unavailable.The released instrument involved would have met manufacturing specifications at the time of production.A risk management review was performed.No additional risks were identified as result of the reported event.A visual inspection was performed.During the inspection marks and scratches were observed throughout the length of the device.Laser markings were seen to be slightly faded but legible.Both cap screws on the head of the instrument appear to be missing.A functional evaluation was performed on the device, it was found that one of the arms of the device was non functional and immobile when screwing the device head.This renders the product non-functional for it's intended use.This confirms the reported complaint.Based on the available information, returned instrument findings and the age of the instrument, a probable cause may be due to an end of life problem.If additional information becomes available in the future, this case will be reopened.Based on this investigation, the need for corrective or preventative action is not indicated.The instrument cannot be repaired and will be retained at aurora.

• Brand Name: BHR HI PERF 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, TX 78735 ; 5123913905
• MDR Report Key: 12616199
• MDR Text Key: 275976270
• Report Number: 3005975929-2021-00469
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010503237
• UDI-Public: 03596010503237
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900001
• Device Catalogue Number: 900001
• Device Lot Number: S0703002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1