MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BURR 5.5MM BARREL 180MM LONG HIGH VIS; SAW, POWERED, AND ACCESSORIES

Model Number 72203131

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

Patient Problems Foreign Body In Patient (2687); Metal Related Pathology (4530); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use the burr sheath systematically released metal into the patient.The metal debris was cleaned up from the patient.The procedure was completed with a s+n back up device.It is unknown if there was a delay and no other complications were reported.

Event Description

It was reported that during a hip arthroscopy the burr sheath systematically released metal into the patient.The metal debris was cleaned up from the patient.The procedure was completed with a s+n back up device.A significant delay and no other complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

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.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 concluded this was a repeat issue.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 relationship, if any, between the subject device and the reported event could not be determined.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 evaluation will be reopened for investigation.H6: updated codes.

Manufacturer Narrative

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

Manufacturer Narrative

B5 and h6 updated.H3, h6: the device was received for evaluation.A visual inspection revealed three devices were returned in the carton.The devices were sealed and free of damage.A functional evaluation revealed the three devices function as intended clockwise, counter clockwise, and while oscillating.There was no shedding during functional 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 no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that the metal debris was retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.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.

Event Description

It was reported that during a hip arthroscopy the burr sheath systematically released metal into the patient.The metal debris was cleaned up from the patient.The procedure was completed with a s+n back up device with a delay greater than 30 minutes.There were no other complications reported.

• Brand Name: BURR 5.5MM BARREL 180MM LONG HIGH VIS
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11943069
• MDR Text Key: 254521006
• Report Number: 1643264-2021-02072
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 00885554025514
• UDI-Public: 00885554025514
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: 72203131
• Device Catalogue Number: 72203131
• Device Lot Number: 50909741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2020
• 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; Other