MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BLADE 3.5MM DISP; SAW, POWERED, AND ACCESSORIES

Model Number	7205305
Medical Device Problem Codes	Overheating of Device (1437); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case-(b)(4).
Event or Problem Description
It was reported that, during acl reconstruction procedure, the full radius blade 3.5mm disp presented a "blade stall" error message when connected to the handpiece and it was overheating.Procedure was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A visual inspection revealed the device was not returned with original packaging and the device looks like it has debris on it, possibility of lubricant.No other physical damage is visible to the device.A functional evaluation of the returned device found that device is in working order, device did not stall or overheat.Device passed all functional test.Device functioned as per manufacture spec.A complaint history review found similar reported events.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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: FULL RADIUS BLADE 3.5MM DISP
• 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: 12356634
• Report Number: 1219602-2021-01773
• Device Sequence Number: 12687254
• Product Code: HAB
• UDI-Device Identifier: 03596010251336
• UDI-Public: 03596010251336
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 01/08/2026
• Device Model Number: 7205305
• Device Catalogue Number: 7205305
• Device Lot Number: 50915045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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