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

Model Number	72202531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The sample is under evaluation by the manufacturing site.
Event or Problem Description
It was reported that during set up of an ankle scope surgery the full radius bonecutter 4.5mm platinum while the tip of the blade was activated it showed a malfunction, the blade was not functioning.The procedure was successfully completed without a significant delay using a back-up device.No patient injury or other complications were reported.Preliminary results of investigation have concluded that this unit had a fracture distal tip which makes it a reportable event.
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).H10 h3, h6: the reported device was returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image reveals the inner blade is fractured and worn.A visual inspection revealed the device was received outside of original packaging.The inner blade distal tip was fractured.A functional evaluation reveals the device does not function as intended due to fracture of the inner blade.It was determined the device contributed to the reported event.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate application, excessive force and side loading of the device.No containment or corrective actions are recommended at this time.

• 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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12451588
• Report Number: 1219602-2021-01923
• Device Sequence Number: 1194605
• Product Code: HAB
• UDI-Device Identifier: 00885554027891
• UDI-Public: 00885554027891
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 03/12/2022
• Device Model Number: 72202531
• Device Catalogue Number: 72202531
• Device Lot Number: 50827971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown