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

Model Number 72202972

Device Problems Material Fragmentation (1261); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).Preliminary results of investigation found that the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident. 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 review of the part drawing found that the drill shaft is straight and in one continuous piece.An analysis of the customer provided image revealed a significant amount of bending and deformation along the drill shaft.A visual inspection of the returned device found that the drill bit is bent and the shaft is fractured in multiple places throughout.The laser etching in the side is worn, and there is debris on the device. the complaint was confirmed. 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.

Event Description

It was reported that, during set up, the drill flexible endoscpc cann 5mm was damaged.The malfunction was solved with no delays or patient harm using a back up device.Results of investigation have concluded that the shaft of the device is fractured in multiple places throughout which makes it a reportable event.

Manufacturer Narrative

H10: h3, h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was an isolated event.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 review of the part drawing found that the drill shaft is straight and in one continuous piece.An analysis of the customer provided image revealed a significant amount of bending and deformation along the drill shaft.A visual inspection of the returned device found that the drill bit is bent and the shaft is fractured in multiple places throughout.The laser etching in the side is worn, and there is debris on the device.The complaint was confirmed.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 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: 12800179
• MDR Text Key: 282044875
• Report Number: 1219602-2021-02494
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202972
• Device Catalogue Number: 72202972
• Device Lot Number: 50611784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1