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

Catalog Number 7210499

Device Problems Flaked (1246); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that during a knee arthroscopy, there were presence of numerous metal chips with the use of two disposable blade elite.It is unknown if there was a back-up device available.The surgery was delayed but it is unknown the specific interval of delay.The patient´s knee was washout and no further complications were reported.

Event Description

It was reported that during a knee arthroscopy, there were presence of numerous metal chips with the use of two disposable blade elite.It is unknown if there was a back-up device available.The surgery was delayed but it is unknown the specific interval of delay.The patient´s knee was washout and no further complications were reported.The shredded material was retrieved from the patient with suction/cleaning, however not all shred/flaked material were retrieved from the patient.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 b1, b2, b5, h1 and h6: updated.

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.A visual evaluation showed each of the two devices were returned with original packaging with the batch number of the complaint on the label.The color scheme of the devices match the print.Both outer blades have heavy scratches/grooves from being in contact with other sharp instruments.Both the inner blades have heavy scoring/grooves caused from debris caught between the inner and outer blades during use.The teeth of the inner blade have been heavily used and show sign of wear.There are metal shavings inside the outer blade adaptor body.A functional evaluation revealed that manually separating the inner blade from outer blade, on both devices, drug and ground, with slight resistance, due to the metal shavings caught between the two pieces.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that no clinical factors were found which would have contributed to the reported events and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.It is unclear if the device instructions for use was adhered to as it was noted that ¿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.¿ ¿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.¿ the material of the blade is 304 stainless steel and is intended as an externally communicating device, not approved for implantation; therefore, long-term implantation data is not available.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration cannot be determined.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include excessive side-loading and minimal irrigation.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: 18416124
• MDR Text Key: 331602969
• Report Number: 1219602-2023-02551
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7210499
• Device Lot Number: 51119671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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; Required Intervention