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

Model Number	72202531
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10293008
• Report Number: 1219602-2020-01079
• Device Sequence Number: 10993709
• Product Code: HAB
• UDI-Device Identifier: 00885554027891
• UDI-Public: 00885554027891
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention