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

Catalog Number	72202531
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ankle arthroscopy, the blade broke inside the patient and it stopped working (it only went forward, not in reverse or oscillating).The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 4.5mm platinum full radius bonecutter intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the blade broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive side loading of the blade during use.The instruction for use were reviewed and were 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: FULL RADIUS BONECUTTER, 4.5MM, PLATINUM
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9302730
• Report Number: 1219602-2019-01404
• Device Sequence Number: 2362585
• Product Code: HAB
• UDI-Device Identifier: 00885554027891
• UDI-Public: 00885554027891
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 12/21/2019

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: 10/01/2021
• Device Catalogue Number: 72202531
• Device Lot Number: 50797380
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 12/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1