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

Model Number 72202531

Device Problem Material Twisted/Bent (2981)

Patient Problem Burn(s) (1757)

Event Date 06/29/2020

Event Type  malfunction  

Event Description

It was reported that during meniscus repair surgery, when the device was being used, the shaft was bent and heat was generated by friction causing the patient to be burned around the portal.No delay or other complications were reported.It is unknown how the procedure was completed.

Manufacturer Narrative

The reported 4.5mm platinum full radius bonecutter, used in treatment, was returned for evaluation.Visual assessment showed the inner and outer blades are bent.There is no evidence that indicates the blade heated up as the polycarbonate components show no melting.The condition of the device indicates it was subjected to excessive side loading during use.Per the device ifu 1060595 under precautions ¿excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly¿.A review of the manufacturing and complaint records was performed for the reported device, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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: 10293008
• MDR Text Key: 199445181
• Report Number: 1219602-2020-01079
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554027891
• UDI-Public: 00885554027891
• Combination Product (y/n): N
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202531
• Device Catalogue Number: 72202531
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 09/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention