MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR SLEEVE CUTTER SZ 50; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 90127600

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Event Description

It was reported that, during set up inspection process, was noticed that the birmingham hip sleeve cutter size 50 is dull.The procedure was completed using a smith and nephew back up device, with no surgical delay and no injury to the patient.

Manufacturer Narrative

A bhr sleeve cutter size 50 (90127600, 18.231386) was returned for investigation, reported as dull.A visual inspection was performed, which noted small number of marks and scratches across the device, consistent with surgical use.The cutting edges have been dulled, with some being slightly deformed.This confirms the reported complaint.A review of the complaint history for the bhr sleeve cutter 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.The production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.Based on the available information, the proposed probable root cause for the failure is expected wear.Smith and nephew recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No preventative or corrective action has been initiated as a result of this investigation.The device cannot be repaired and will be retained.

• Brand Name: BHR SLEEVE CUTTER SZ 50
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire ; UK
• MDR Report Key: 10815959
• MDR Text Key: 215489208
• Report Number: 3005975929-2020-00427
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533388
• UDI-Public: 03596010533388
• 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: 12/06/2020

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: 90127600
• Device Catalogue Number: 90127600
• Device Lot Number: 18231386
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RESURFACING FEMORAL HEAD 50MM (74121150); RESURFACING FEMORAL HEAD 50MM (74121150)