MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC; ACCESSORIES,ARTHROSCOPIC

Model Number 72201108

Device Problems Material Fragmentation (1261); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2020

Event Type  Injury  

Event Description

It was reported that during a procedure, the drill was dropping emalia.Procedure was successfully completed with the same device.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported 2.6 mm bioraptor drill, used in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the drill shed during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: bending or flexing of the drill during drilling causing it to contact the drill guide.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the device, there are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records could not be performed due to insufficient information but 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer provided image found an arthroscopic image of a fragmented silver substance inside of the patient.A visual inspection found scratches on both ends of the device.The material, which is manufactured and intended as an externally communicating device, is not approved for implantation; therefore, long-term implantation data is not available.No patient injuries have been reported, however if retained the patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.No further medical assessment can be rendered at this time.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 an application of unintended inappropriate or excessive force to the device, off-axis insertion, attempted correction of a damaged device, or an impact event inconsistent with normal use.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.

Manufacturer Narrative

Internal complaint reference case-(b)(4).

• Brand Name: DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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 ¿; 5123913905
• MDR Report Key: 10151813
• MDR Text Key: 195077905
• Report Number: 1219602-2020-00923
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010595034
• UDI-Public: 03596010595034
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 72201108
• Device Catalogue Number: 72201108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 02/13/2023; 05/22/2023
• Supplement Dates FDA Received: 08/21/2020; 02/14/2023; 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention