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

Model Number 72203521

Device Problem Flaked (1246)

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

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that during arthroscopy procedure, inside the patient, the 4.5mm full radius platinum series was leaving marks on patient's tissue.The procedure was finished with a smith and nephew backup device.No surgical delay.Patient injuries were not reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history 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 a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as pre-cautions 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 device was coated in debris at the distal tip.Signs of wear visible.No physical damage visible.A functional evaluation revealed that the device functioned as intended clockwise, counter clockwise and while oscillating.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: 4.5MM FULL RADIUS PLATINUM SERIES
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12317948
• MDR Text Key: 266371349
• Report Number: 1219602-2021-01709
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554024333
• UDI-Public: 00885554024333
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203521
• Device Catalogue Number: 72203521
• Device Lot Number: 50920994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention