MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5MM ABRADER 180MML DISPOSABLE (3; SAW, POWERED, AND ACCESSORIES

Model Number	72200082
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a hip arthroscopy with labral repair, when the abrader burr was used, metal fillings were disbursed everywhere once engaged.Most of the fillings were removed by suction and lavage.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the reported device, used in treatment, 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 subject 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.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 review of risk management files found that the reported failure was documented appropriately.A review of the customer provided image reveals what appears to be speckles of metal fillings inside the patient.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended force and side loading of the device, leading to premature wear.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned with original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.Magnets are in place.There is scoring with bio debris at the proximal end of the inner blade.A functional evaluation of the device found that when connected to a reference mdu, it spins as intended without grinding, seizing, or unexpected noise.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.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 review of risk management files found that the reported failure was documented appropriately.A review of the customer provided image reveals what appears to be speckles of metal fillings inside the patient.The root cause of the reported event could not be determined since findings can not lead to a clear cause of the reported event.Factors, which could have contributed to the complaint event, include an application of unintended force and side loading of the device, leading to premature wear.No containment or corrective actions are recommended at this time.H11: corrected information in b5.
Event or Problem Description
It was reported that during a surgery the hip arthroscopy with labral repair the 5.5mm long abrader burr was inserted, the metal fillings were disbursed everywhere once engaged, most of the fillings were removed with the suction and lavage.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.It was reported that during a surgery the hip arthroscopy with labral repair the 5.5mm long abrader burr was inserted, the metal fillings were disbursed everywhere once engaged, most of the fillings were removed with the suction and lavage.The procedure was successfully completed without a significant delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed the device was returned with original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.Magnets are in place.There is scoring with bio debris at the proximal end of the inner blade.A functional evaluation of the device found that when connected to a reference mdu, it spins as intended without grinding, seizing, or unexpected noise.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 no 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.A review of the customer provided image reveals what appears to be speckles of metal fillings inside the patient.A clinical root cause could not be determined.The abrader burr and resulting metal filings is an externally communicating device that is neither manufactured nor intended for implantation; therefore, no long-term exposure with skin or tissue (implantation) data is not available.The patient impact is determined to be the reported device breakage/retained foreign body during the hip arthroscopy.Although unlikely, the potential for corrosion and local irritation/migration of the burr fragments could not be ruled out.No further medical assessment can be rendered at this time.The root cause of the reported event could not be determined since findings can not lead to a clear cause of the reported event.Factors, which could have contributed to the complaint event, include an application of unintended force and side loading of the device, leading to premature wear.Based on this investigation, the need for corrective action is not indicated.H11: corrected information in h6 (type of investigation, investigation findings) and h10.

• Brand Name: BURR 5.5MM ABRADER 180MML DISPOSABLE (3
• 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: 11773766
• Report Number: 1219602-2021-01022
• Device Sequence Number: 14397462
• Product Code: HAB
• UDI-Device Identifier: 03596010541529
• UDI-Public: 03596010541529
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/22/2024

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 Expiration Date: 06/05/2023
• Device Model Number: 72200082
• Device Catalogue Number: 72200082
• Device Lot Number: 50909731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/02/2021; 05/28/2024; 07/19/2024
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/03/2021; 05/29/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• 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: Required Intervention
• Patient Sex: Unknown