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 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the alignment guide holder broke.This was found during set up / inspection.No surgery or patient involvement.

Manufacturer Narrative

A bhr curved cup introducer (90128257, s08003095) was received for investigation.It was reported that the alignment guide holder broke.A visual inspection was performed.Marks and scratches were noted across the whole length of the instrument, consistent with repeated surgical use.The part of the introducer that mates with the x-bar has broken off at the welds.This confirms the reported complaint.A review of the complaint history for the bhr cup introducer was performed using part and batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the batch.Similar complaints have been identified for the part.Due to the age of the instrument, and as the manufacturer is out of business, the production records could not be retrieved or reviewed for the instrument reportedly involved in this incident.However, all the released instruments involved would have met manufacturing specifications at the time of production.This instrument had a lifespan of 12+ years and it is unknown how many surgical cycles it was involved in during this time.Based on the available information and the returned instrument the probable root cause is an end of life problem.If further information is received then the complaint will be reopened and investigated.No corrective or preventative actions have been initiated as a result of the performed investigation.The instrument will be retained at aurora uk as it cannot be repaired.

• 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
• MDR Report Key: 11072446
• MDR Text Key: 227071433
• Report Number: 3005975929-2020-00517
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533791
• UDI-Public: 03596010533791
• Combination Product (y/n): N
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• 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: S08003095
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1