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	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the alignment guide holder broke.This was found during set up / inspection.No surgery or patient involvement.
Additional 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
• 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
• MDR Report Key: 11072446
• Report Number: 3005975929-2020-00517
• Device Sequence Number: 19648509
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2021

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: S08003095
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1