MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RAZORCUT 3.5MM,EP-1,DISP BLD; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205317
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during the acl reconstruction procedure, when the device was shaving the planned femoral bone hole, it was bent and broken; the device did not break inside of the patient.The procedure was completed with a back-up device.No patient injury was reported.5 minutes delay was reported.No product to return.
Additional Manufacturer Narrative
One 3.5mm razorcut blade was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.The inner and outer blades have broken approximately mid-point of their length.There is also significant cracking of the adapter body.The condition of the blade indicates it was subjected to excessive side loading.Per the devices instructions for use ¿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¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during an acl reconstruction procedure when the device was shaving the planned femoral bone hole, it was bent and broken.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The reported 3.5mm razorcut, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the blade bent then broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: applying an excessive lateral load during use.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: RAZORCUT 3.5MM,EP-1,DISP BLD
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9072869
• Report Number: 1219602-2019-01125
• Device Sequence Number: 1748599
• Product Code: HAB
• UDI-Device Identifier: 03596010251459
• UDI-Public: 03596010251459
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2023
• Device Catalogue Number: 7205317
• Device Lot Number: 50770085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/17/2019; 09/26/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 09/18/2019; 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1