MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM SYNOVATOR PLATINUM SERIES; SAW, POWERED, AND ACCESSORIES

Model Number	72203523
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy, the surgeon observed that debris had come from the working end of the synovator shaver blade into the joint; it was stated the shaver blade was "under no pressure".The debris was removed by irrigation.The procedure was successfully completed with non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H6, health effect - clinical code was updated.H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection of the returned device found that is not in its original packaging.The inner shaft is bent.Both the housing and inner shaft and blade have discoloration and debris on and in them.A functional assessment of the device found that the inner blade rubs against the housing during some rotations.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device or inappropriate storage conditions.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.The two provided undated/unlabeled intra-operative photos were reviewed and appear to show multiple small linear shaped pieces which were of a grayish/black color (and unknown consistency) surrounded by tissue.As of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The patient impact beyond the reported events cannot be determined.The patient¿s current health status is unknown.Therefore, no further clinical medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case may be re-assessed.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.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.No containment or corrective actions are recommended at this time.

• Brand Name: 4.5MM SYNOVATOR PLATINUM SERIES
• 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: 15398014
• Report Number: 1219602-2022-01351
• Device Sequence Number: 5006823
• Product Code: HAB
• UDI-Device Identifier: 00885554027839
• UDI-Public: 00885554027839
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72203523
• Device Catalogue Number: 72203523
• Device Lot Number: 51002229
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 09/11/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown