MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INCISOR BLADE 3.5MM DSPL EP-1; SAW, POWERED, AND ACCESSORIES

Model Number	7205312
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a meniscal suture procedure, the 'incisor blade' overheated, being impossible to hold it in the hand.Also, when the blade was placed, it did not rotate.It was not possible to remodel the joint since there was no replacement available.The procedure was completed with a non-significant delay using a competitor device.No patient injuries or other complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during a meniscal suture procedure, the 'incisor blade' overheated, being impossible to hold it in the hand.Also, when the blade was placed, it did not rotate.It was not possible to remodel the joint since there was no replacement available.The procedure was completed with a non-significant delay using a competitor device.No patient injuries or other complications were reported.
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.A complaint history review concluded this was an isolated event.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 there was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device 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.¿.
Additional Manufacturer Narrative
H10: h2: additional information on d9.H3, h6: the reported device was returned for evaluation.A complaint history review found no similar 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.A visual inspection found the device was returned taped to the product label.The tape left residue on the device when it was removed.The inner blade had scuffs.A functional evaluation found the device functioned as intended and did not heat up, even when run without irrigation.It was determined the device did not contribute to the reported event.The complaint was not confirmed.Factors, which could have contributed to the complaint event, include a failure of a concomitant device.No containment or corrective actions are recommended at this time.H11: correction on h6 (health effect - impact code).

• Brand Name: INCISOR BLADE 3.5MM DSPL EP-1
• 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: 13472611
• Report Number: 1219602-2022-00161
• Device Sequence Number: 5233235
• Product Code: HAB
• UDI-Device Identifier: 03596010251404
• UDI-Public: 03596010251404
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2023

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: 11/01/2024
• Device Model Number: 7205312
• Device Catalogue Number: 7205312
• Device Lot Number: 50840658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/08/2022; 04/21/2023
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/09/2022; 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Male