MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCPC CANN 5MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72202972

Device Problem Break (1069)

Patient Problems Perforation (2001); Rupture (2208)

Event Date 08/29/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during an arthroscopy a tunnel was made with the drill flexible endoscopic cann, however the specialist did not like the position very much, and did a second tunnel, where the drill broke.At the end, the doctor stuck with the first tunnel option, the broken parts of the drill were completely removed.No delay was reported, and the procedure was finished with a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

H10: 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 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 provided image finds the complaint device, with the drill tip fractured off from the flexible shaft.Per case details, the broken parts of the drill were retrieved from the patient.The procedure was completed using a back-up device.No further risk to the patient is anticipated as a result of the additional bone hole.Since no further harm is anticipated no further clinical assessment is warranted 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 excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, or an inadvertent 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

H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The shaft is fractured about 1/4 of the way into the flexible portion and again at the distal end.The drill bit is fractured away and was not returned.A review of the customer provided image finds the complaint device, with the drill tip fractured off from the flexible shaft.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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.The root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, or an inadvertent impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.H11: corrected information in h6 (health effect - clinical code).

• Brand Name: DRILL FLEXIBLE ENDOSCPC CANN 5MM
• 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, TX 78735 ; 5123913905
• MDR Report Key: 15462925
• MDR Text Key: 300367191
• Report Number: 1219602-2022-01407
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: 03596010654533
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2023

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
• Device Operator: Health Professional
• Device Model Number: 72202972
• Device Catalogue Number: 72202972
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/22/2022
• Supplement Dates Manufacturer Received: 11/17/2022; 10/17/2023
• Supplement Dates FDA Received: 11/21/2022; 10/23/2023
• 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): Other; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male