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

Model Number 90128257

Device Problem Crack (1135)

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

Event Date 09/02/2020

Event Type  malfunction  

Event Description

It was reported that upon inspection the device was found with a cracked weld.No case involved.

Manufacturer Narrative

A bhr curved introducer (part 90128257, lot s0704032) was returned for inspection after reporting that the instrument was found with a cracked weld.A visual inspection was performed, which noted mark and scratches across the whole device, consistent with surgical use.There is a cracked weld on the instrument.There is impact damage to the head.This confirms the reported complaint.A review of the complaint history for the bhr curved cup introducer was performed using part and batch numbers in search of similar recurring reports for the products during their lifetimes.Similar complaints have been identified.This will continue to be monitored.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 expected wear/tear.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: 10597867
• MDR Text Key: 209234502
• Report Number: 3005975929-2020-00366
• 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
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

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
• Device Operator: Health Professional
• Device Model Number: 90128257
• Device Catalogue Number: 90128257
• Device Lot Number: S0704032
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1