MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCPC CANN 4.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72202971
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: case- (b)(4).
Event or Problem Description
It was reported that during an unspecified procedure, when drilling the cortex of the femur with the 4.5mm flexible drill, it split and it had to be drilled with the auger 5.0mm from the outside to the inside.It is unknown how the procedure was completed or if there was a surgical delay.No further complications were reported.
Additional Manufacturer Narrative
H10: b5 updated.
Event or Problem Description
It was reported that during an acl reconstruction, lateral condile procedure, when drilling the cortex of the femur with the 4.5mm flexible drill, it split and it had to be drilled with the auger 5.0mm from the outside to the inside.The procedure was completed with a 3 minutes surgical delay using a back-up device in the originally drilled bone hole.No further complications were reported.The current status of the patient is well.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10 h3, h6: the reported device 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 device and the reported event.A complaint history review found similar reported events.A review of device records showed 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the customer supplied images finds partial images of the complaint device.It appears the blade portion is fractured away.This case reports, the flexible drill split during drilling in an acl reconstruction, lateral condyle procedure and the auger 5.0 mm was then drilled from outside to inside.Per case details, the patient¿s current health status is well.However, it is unknown if the drill broke internal to the patient or if any broken pieces fell inside the patient.The material composition of the of the flexible drill is 465 sst.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The drills are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort 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, 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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was returned to the designated complaint unit for independent evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.A review of device records showed 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 was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.There were 3 devices returned.A visual inspection of the complaint device found that it is not in its original packaging.The drill is warped through the area of flexibility and the distal tip is broken away on an unknown guide wire.There is biological debris in the device.A visual inspection of an additional returned device found that it is not in its original packaging.The lot number is 50821659 drill is warped through the area of flexibility and the proximal end of the flexible portion is cracked.There is biological debris in the device.A visual inspection of an additional returned device found that it is not in its original packaging.The lot number is 50864013 drill is warped through the area of flexibility and the proximal end of the flexible portion is bent at almost 90 deg.There is biological debris in the device.A review of the customer supplied images finds partial images of the complaint device.It appears the blade portion is fractured away.¿¿a review of the customer supplied images finds partial images of the complaint device.It appears the blade portion is fractured away.This case reports, the flexible drill split during drilling in an acl reconstruction, lateral condyle procedure and the auger 5.0 mm was then drilled from outside to inside.Per case details, the patient¿s current health status is well.However, it is unknown if the drill broke internal to the patient or if any broken pieces fell inside the patient.The material composition of the of the flexible drill is 465 sst.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.The drills are manufactured and intended as externally communicating devices and are not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond possible micro-motion and/or migration, and local irritation/discomfort 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, 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.

• Brand Name: DRILL FLEXIBLE ENDOSCPC CANN 4.5MM
• Common Device Name: 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, TX 78735 ; 5123913905
• MDR Report Key: 14956346
• Report Number: 1219602-2022-00977
• Device Sequence Number: 5586516
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: 03596010654526
• Combination Product (Y/N): N
• 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: Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50832610
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 07/12/2022; 08/10/2022; 02/03/2023
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 07/13/2022; 08/11/2022; 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• 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