MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM INCISOR PLUS PLATINUM BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	72203013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a knee procedure using an incisor plus platinum blade, when the shaver was advanced into the joint, the tip of the shaver popped off in the patient.The broken piece was retrieved in full.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H10 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 a relationship found between the returned device and the reported 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.A complaint history review found no similar reported events.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.Without the requested clinically relevant supporting documentation, the root cause of the reported ¿tip of the shaver popped off¿ cannot be definitively concluded.The patient impact beyond the reported is not anticipated as the broken piece was ¿fully retrieved¿ from the patient using a backup device with a non-significant procedural delay.No patient harm has been alleged.Therefore, no further clinical/medical assessment can be rendered.A review of the customer provided images found the blade pictured with the distal tip of the outer blade sheared off and separated from the rest of the blade assembly.The complaint was confirmed but the root cause could not be determined as the device has not been returned for evaluation.Factors that may have contributed to the reported event include an unintended impact force to the tip of the device or excessive side loading.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual evaluation showed the failed device was returned with the tyvek lidstock showing the batch number of the complaint on it.The distal tip of the outer blade is broken off at the weld.There is scarring on the inside of the broken distal piece and damage to the top/distal portion of the window of the broken piece.The other seven blades were returned in factory sealed trays with the batch number of the complaint on the tyvek lids.A review of the customer provided images found the blade pictured with the distal tip of the outer blade sheared off and separated from the rest of the blade assembly.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 found no similar reported events.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.Without the requested clinically relevant supporting documentation, the root cause of the reported ¿tip of the shaver popped off¿ cannot be definitively concluded.The patient impact beyond the reported is not anticipated as the broken piece was ¿fully retrieved¿ from the patient using a backup device with a non-significant procedural delay.No patient harm has been alleged.Therefore, no further clinical/medical assessment can be rendered.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that may have contributed to the reported event include an unintended impact force to the tip of the device or excessive side loading.No containment or corrective actions are recommended at this time.

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• 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: 14836356
• Report Number: 1219602-2022-00916
• Device Sequence Number: 4832610
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2023

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 Model Number: 72203013
• Device Catalogue Number: 72203013
• Device Lot Number: 50982770
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 10/26/2023
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/04/2022; 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• 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: Other
• Patient Sex: Unknown