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

Model Number 90127613

Device Problem Dull, Blunt (2407)

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

Event Date 10/26/2020

Event Type  Injury  

Event Description

It was reported that, during set up inspection process, was noticed that the birmingham hip plan cutter large 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 plan cutter large (90127613, 8223420001) was received for investigation.It was reported the cutter is dull.Visual inspection was performed which noted that the instrument has marks and scratches along the device, consistent with surgical use.Various cutting blades on the instrument are dulled, with some having slight deformation.This confirms the reported complaint.A review of the complaint history for the birmingham hip plan cutter large was performed using batch numbers in search of similar recurring reports for the instrument during its lifetime.No other similar complaints were identified for the instrument.Due to the age of the instrument, the dhr for this instrument is not available.Therefore, the dhr for this device cannot be reviewed.However, the released instrument involved would have met manufacturing specifications at the time of production.It is unknown how many surgical cycles this instrument has been involved in during its 11+ year life span.The probable root cause is the product reaching the end of its useful life.No preventative or corrective action has been initiated as a result of this investigation.The instrument will be retained at aurora as it cannot be reworked or repaired.

• Brand Name: BHR PLAN CUTTER LARGE
• 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: 10815960
• MDR Text Key: 215495926
• Report Number: 3005975929-2020-00428
• Device Sequence Number: 1
• Product Code: NXT
• UDI-Device Identifier: 03596010533487
• UDI-Public: 03596010533487
• 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: 12/10/2020

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: 90127613
• Device Catalogue Number: 90127613
• Device Lot Number: 8223420001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/10/2020
• 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)