MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM SYN PLAT CONC CURVED BLD; SAW, POWERED, AND ACCESSORIES

Catalog Number	72205110
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy, the surgeon noticed a loose metal fleck on the side of the synovator platinum blade.The blade was pulled out from the knee joint and the metal fleck was wiped off.No piece fell inside the joint, since the surgeon noticed the problem in time.The procedure was completed using the same reported device.There was a surgical delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However an image evaluation was performed and found two arthroscopic pictures of the side of the synovator platinum blade, where a unidentified material can be seen.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.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 root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include debris from a concomitant device.No containment or corrective actions are recommended at this time.

• Brand Name: 4.5MM SYN PLAT CONC CURVED BLD
• 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: 18692175
• Report Number: 1219602-2024-00271
• Device Sequence Number: 15583094
• Product Code: HAB
• UDI-Device Identifier: 00885556708910
• UDI-Public: 00885556708910
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: 03/04/2025
• Device Catalogue Number: 72205110
• Device Lot Number: 50860706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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