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
One used 4.5mm full radius bonecutter platinum blade was returned for evaluation.The blade was evaluated for rotation and was found not to rotate freely.Visual assessment of the inner blade edgeform showed it is rolled over and dented and is missing several small pieces.The inner blade distal tip is also bent.A corresponding contact point was observed on the outer blade edge form.The edgeform damage appears to be caused by an contact with the outer edgeform during rotation.The devices condition is consistent with excessive side loading being applied during use.Per the device instruction for use 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¿.

• 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: 9302726
• Report Number: 1219602-2019-01402
• Device Sequence Number: 2104317
• 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): 12/11/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1