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

Model Number 72203013

Device Problem Material Discolored (1170)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/14/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that during a shoulder labral repair, the platinum blade had black marks.This black marks were left on the patient's white tissue and they looked like pencil markings.The procedure was completed without delay using the same device.No patient injury or other complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).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.There was no way to determine if the device contributed to the reported event.A complaint history review found similar reported 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.No clinical information was provided for review, nor was the device returned for evaluation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the possible retained debris cannot be determined.No further clinical/medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: 4.5MM INCISOR PLUS PLATINUM BLADE
• Type of Device: 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: 12137366
• MDR Text Key: 260552997
• Report Number: 1219602-2021-01531
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010655660
• UDI-Public: 03596010655660
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72203013
• Device Catalogue Number: 72203013
• Device Lot Number: 50920990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other