MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE,SAPHYRE II, 90DEG,3MM,SUCTION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	7210111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a shoulder rotator repair, instruments inside patient, the wand shaft of the probe was broken, cannot work.The patient was under anesthesia when the delay occurred.The procedure was completed with a s+n back up device.A significant delay and no patient injury or other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found a small, round puncture to the shaft.A functional evaluation could not produce any cautery at the electrodes of the device.The customer provided images were found to display the same damage to the device found in the investigator's visual inspection.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 a repeat issue.The complaint was verified.Factors that may have contributed to the reported incident include an impact force with another object.No containment or corrective actions are recommended at this time.

• Brand Name: PROBE,SAPHYRE II, 90DEG,3MM,SUCTION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 12533104
• Report Number: 3003604053-2021-00250
• Device Sequence Number: 11113213
• Product Code: GEI
• UDI-Device Identifier: 03596010481498
• UDI-Public: 03596010481498
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 05/04/2023
• Device Model Number: 7210111
• Device Catalogue Number: 7210111
• Device Lot Number: 2055608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 55