MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FULL RADIUS BL 4.5MM DSPL. EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205306
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a synovectomy the full radius blade had a failure, the synovium tears up, it caused bleeding and it was relieved after using hemostasis with radiofrequency.It is unknown if there was an available back up device or a significant delay during the procedure.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.Based on the information provided, the reported bleeding was relieved after using hemostasis with radiofrequency.However, it is unknown if there was an available backup device or if there was a significant delay during the procedure.Since no other complications were reported, no further clinical/medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Event or Problem Description
It was reported that during a synovectomy the full radius blade had a failure, the synovium tears up, it caused bleeding and it was relieved after using hemostasis with radiofrequency.Patient has been recovered.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.

• Brand Name: FULL RADIUS BL 4.5MM DSPL. EP-1
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 12158353
• Report Number: 1219602-2021-01544
• Device Sequence Number: 4260076
• Product Code: HAB
• UDI-Device Identifier: 03596010251343
• UDI-Public: 03596010251343
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2021

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 Expiration Date: 01/14/2025
• Device Model Number: 7205306
• Device Catalogue Number: 7205306
• Device Lot Number: 50851716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 07/27/2021; 07/25/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/28/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Weight: 58