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

Catalog Number	7210499
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a procedure, particles were released into the patient's joint, even though the disposable blade device was not locked.There was presence of a foreign body in the patients body.It is unknown how the procedure was completed or if there was a delay.No further complications were reported.
Additional Manufacturer Narrative
H10: h2: additional information b5, d9, h6.
Event or Problem Description
It was reported that during a shoulder arthroscopy, particles were released into the patient's joint, even though the disposable blade device was not locked.There was presence of a foreign body in the patient's body.It is possible that all the particles were removed from the patient using suction.The procedure was completed using a smith and nephew back up device.There was a 20-min delay and no further complications were reported.
Additional Manufacturer Narrative
Health effect - impact code updated.H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.The blade/teeth are still sharp.Bio debris is present on both blades and around the upper proximal end of the inner blade, but no abrasion or scoring is observed.There is no evidence of abrasion or scoring on the inner or outer blade.A functional evaluation of the device found that when connected to a reference mdu, it spins as intended at 2000 and 5000 rpm without grinding, seizing, or unexpected noise.No particles were observed in the clear fluid during testing.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 similar reported events.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.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.Although responses to the information requests were not provided, it was reported that foreign body particles were released into the patients joint.The current patient status is unknown.The instructions for use does caution against inner blade wear/damage/deformation due to excessive side loading/contact with metallic objects/dry use, etc¿ the patient impact includes the reported foreign body/unspecified amount of particles in the patient¿s joint which may incur risks of corrosion, local irritation/discomfort, and/or migration of foreign body fragments.Further impact to the patient cannot be determined based on the information provided within the complaint.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process factors that can contribute 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.
Additional Manufacturer Narrative
Results of investigation were updated: the reported device was received for evaluation.A visual evaluation showed the device was returned in original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.The blade/teeth are still sharp.Bio debris is present on both blades and around the upper proximal end of the inner blade, but no abrasion or scoring is observed.There is no evidence of abrasion or scoring on the inner or outer blade.A functional evaluation of the device found that when connected to a reference mdu, it spins as intended at 2000 and 5000 rpm without grinding, seizing, or unexpected noise.No particles were observed in the clear fluid during testing.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 similar reported events.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.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.It was reported that the procedure was completed with a same reference backup device within a 20 minute surgical delay, and per complaint details, foreign body particles were released into the patients joint.The current patient status is unknown.The ifu does caution against inner blade wear/damage/deformation due to excessive side loading/contact with metallic objects/dry use, etc¿ the patient impact includes the reported foreign body/unspecified amount of particles in the patient¿s joint which may incur risks of corrosion, local irritation/discomfort, and/or migration of foreign body fragments.Further impact to the patient cannot be determined based on the information provided within the complaint.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process factors that can contribute 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
• 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: 19033204
• Report Number: 1219602-2024-00690
• Device Sequence Number: 7068826
• Product Code: HAB
• UDI-Device Identifier: 03596010494764
• UDI-Public: 03596010494764
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/03/2024

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 Catalogue Number: 7210499
• Device Lot Number: 51152409
• 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: 03/13/2024
• Supplement Date Received by Manufacturer: 04/17/2024; 05/15/2024; 05/29/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 04/23/2024; 05/20/2024; 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2023
• 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