MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE 4.5 DSPL EP-1(BX6); SAW, POWERED, AND ACCESSORIES

Model Number	7205313
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, the 'blade' disassembled inside the patient.The procedure was completed with no delay using a s+n back up device.No further complications were reported.The patient's health condition is stable.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).Foreign zip code: (b)(6).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed, and the root cause 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.A complaint history review found no 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.The attached pilgrim intake form was reviewed, however, it doesn¿t contribute in determining the root cause of the reported failure.Based on the information provided, the ¿blade¿, disassembled and stopped working during use outside of the patient.According to the report, the procedure completed without delay using a s&n back-up device.Since there was no harm alleged to this patient and no other complications reported, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Event or Problem Description
It was reported that during a shoulder arthroscopy, the 'blade' disassembled outside the patient.The procedure was completed with no delay using a s+n back up device.No further complications were reported.The patient's health condition is stable.

• Brand Name: INCISOR BLADE 4.5 DSPL EP-1(BX6)
• 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: 13743371
• Report Number: 1219602-2022-00354
• Device Sequence Number: 4838893
• Product Code: HAB
• UDI-Device Identifier: 03596010251411
• UDI-Public: 03596010251411
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2022

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 Expiration Date: 09/06/2026
• Device Model Number: 7205313
• Device Catalogue Number: 7205313
• Device Lot Number: 50964381
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/24/2022; 04/18/2022
• Initial Report FDA Received Date: 03/12/2022
• Supplement Report FDA Received Date: 04/04/2022; 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female