MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISSECTOR BLUNT CURVED ECTR; ACCESSORIES,ARTHROSCOPIC

Catalog Number	4101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a wrist procedure, the blunt dissector device broke at the distal end of the carpal tunnel; requiring a 20 minute removal procedure using c-arm imaging and extensive extension of the distal incision to find and remove the tip.It is unknown how was the procedure completed.No further complication were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found that the provided photo was reviewed and confirms the reported device breakage which appears to be broken off at the tip.Two pieces of the device are noted in the provided photo.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that per case details, c-arm imaging and extensive extension of the distal incision was reportedly performed to find and remove the device tip.Per the case communication, a regular freer elevator was used to complete the case instead of the curved dissector and the physician denies any unexpected damaged to tissue due to the extension of the incision.The patient impact beyond the reported (device breakage, ¿larger incision,¿ and use of the c-arm imaging and ¿requiring 20 minutes removal procedure¿) is not anticipated since the device was removed.Therefore, no further medical assessment is warranted.The root cause could not be determined since findings cannot lead to a clear cause of the reported event.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: DISSECTOR BLUNT CURVED ECTR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 17808069
• Report Number: 1219602-2023-01847
• Device Sequence Number: 15126394
• Product Code: NBH
• UDI-Device Identifier: 03596010121585
• UDI-Public: 03596010121585
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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 Catalogue Number: 4101
• Device Lot Number: 50961833
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male