MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BONECUTTER 4.5MM PLATINUM; SAW, POWERED, AND ACCESSORIES

Model Number 72202531

Device Problems Flaked (1246); Component Missing (2306)

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

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an arthroscopy, the bonecutter was releasing metal shavings in the joint while the shaver was in use.It was then noticed that there was a visible patch of metal missing from the shaver itself.The pieces were completely retrieved from the patient by suction.The procedure was completed with a s+n back up device.No delay and no other complications were reported.

Manufacturer Narrative

H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A visual inspection revealed the device was returned outside of original packaging.The inner blade was appears to have the silver plating flaked off around the distal tip of the device.No other visible damage to the device.A functional evaluation revealed the device functions as expected.The device made no grinding noise.The complaint was confirmed, the root cause was associated with a component failure.Factors that could have contributed to the reported event include an application of unintended inappropriate, excessive force, or wear of the device.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BONECUTTER 4.5MM PLATINUM
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11828437
• MDR Text Key: 250838818
• Report Number: 1219602-2021-01137
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554027891
• UDI-Public: 00885554027891
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: 72202531
• Device Catalogue Number: 72202531
• Device Lot Number: 50915057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR