MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR PLAN CUTTER SMALL; PROSTHESIS, HIP, SMI-CNSTRAINED, MET/MET, RESURFACING

Catalog Number 90127614

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2020

Event Type  malfunction  

Event Description

It was reported that after a thr the items were found dull from excessive use and need to be replaced.No harm to any patient was discovered and no delay occurred.

Manufacturer Narrative

It was reported that the bhr plan cutter small was found to be dull.The instrument which is used in treatment has been returned for review.It was noted during visual inspection that the cutting edges visually look dull, slight deformation to the cutting blades which confirms the reported complaint.A review of the complaint history for the bhr plan cutter small was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified.As the complaint is not manufacturing related a dhr review was not performed.Based on the available information the probable root cause has been traced to the instrument reaching the end of its useful life due to its age and potential multiple uses in a surgical environment.No preventative or corrective action has been initiated as a result of this investigation.The instrument will be retained at (b)(4) uk.

• Brand Name: BHR PLAN CUTTER SMALL
• Type of Device: PROSTHESIS, HIP, SMI-CNSTRAINED, MET/MET, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa warwickshire CV31 3HL; UK CV31 3HL
• MDR Report Key: 10131043
• MDR Text Key: 194462450
• Report Number: 3005975929-2020-00183
• Device Sequence Number: 1
• Product Code: NXT
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90127614
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/14/2020
• Patient Sequence Number: 1