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

Model Number	7209686
Medical Device Problem Codes	Material Separation (1562); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use for 20 minutes, using the "probe saphyre 90deg", the head metal had a deformation fracture and a rubber deformation contracture.It is unknown if there was a delay.A smith and nephew back up device was available.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).B1, b5, h1, h2 and h6: updated.
Event or Problem Description
It was reported that during use for 20 minutes in a shoulder rotator cuff repair, using the "probe saphyre 90deg", the head metal had a deformation fracture and a rubber deformation contracture.No pieces felt inside the patient.A delay less or equal than 30 minutes were reported.A smith and nephew back up device was available.No other complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: 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.There was a relationship between the subject device and reported event.The customer provided images confirmed the distal tip had fractured and the plastic was deformed.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.Three undated photos of the device was provided for review and confirms the reported.It was communicated via e-mail that the breakage occurred outside of the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The complaint was confirmed.Factors that could have contributed to the reported failure include excessive force.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.

• Brand Name: PROBE SAPHYRE 90DEG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 12129703
• Report Number: 3003604053-2021-00230
• Device Sequence Number: 11690612
• Product Code: GEI
• UDI-Device Identifier: 03596010470560
• UDI-Public: 03596010470560
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K991218
• 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): 07/28/2021

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: 03/27/2023
• Device Model Number: 7209686
• Device Catalogue Number: 7209686
• Device Lot Number: 2055003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 07/28/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 07/20/2021; 07/28/2021
• 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