MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE BL 4.5MM FR ELITE; SAW, POWERED, AND ACCESSORIES

Model Number 7210499

Device Problem Flaked (1246)

Patient Problem No Information (3190)

Event Date 10/27/2020

Event Type  Injury  

Event Description

It was reported that during arthroscopic shoulder surgery, the surgeon was complaining of shedding on the shaver blade.The procedure was completed with the same device and no other complications were reported.Minor delay to clear metal shavings from joint.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the blade assembly process summary confirmed the inner and outer blade are visually inspected for foreign material or discoloration.A review of the instructions for use revealed the following warnings and precautions related to the reported failure: read these instructions completely prior to use.Dyonics disposable arthroscopic blades contain magnets that may be attracted to other instrumentation when placed in direct contact.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance and in extreme cases may result in wear and degradation of the inner assembly.A visual inspection revealed debris and shedding on the inner blade with debris stuck between teeth and around outside of inner blade.Outer blade appears to have degradation.¿¿ a review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed.Factors that could have contributed to the reported event include excessive side-loading and minimal irrigation.

Manufacturer Narrative

Internal complaint reference case-(b)(4).H6: the reported device was received for evaluation.A visual inspection revealed debris and shedding on the inner blade with debris stuck between teeth and around outside of inner blade.Outer blade appears to have degradation.A complaint history review found no 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.A review of the procedure found that each component should be tested and visually inspected for all non-conforming attributes defined in the procedure.Per e-mail communication no patient harm occurred due to the reported shedding.It was also communicated that the metal shavings were removed from the patient.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.It was determined the device did not contribute to the reported event.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive side-loading and minimal irrigation.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.

• Brand Name: DISPOSABLE BL 4.5MM FR ELITE
• 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: 10871861
• MDR Text Key: 217289934
• Report Number: 1219602-2020-01894
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 7210499
• Device Catalogue Number: 7210499
• Device Lot Number: 50888792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 01/20/2021; 04/21/2022
• Supplement Dates FDA Received: 01/22/2021; 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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): Required Intervention