MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCPC CANN.DRL.BIT 4.5 STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7207315

Device Problems Flaked (1246); Dull, Blunt (2407)

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

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during procedure, the endoscopic drill bit was dull and it could not advance easily when making the bone hole.The drill was scratched and it generated a metal powder when overdrilling.The procedure was completed with a backup device and no delay nor further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).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 complaint history review concluded this was a repeat issue.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 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 investigation will be reopened for evaluation.

• Brand Name: ENDOSCPC CANN.DRL.BIT 4.5 STRL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 12340142
• MDR Text Key: 267212944
• Report Number: 1643264-2021-02263
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 03596010425409
• UDI-Public: 03596010425409
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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: 7207315
• Device Catalogue Number: 7207315
• Device Lot Number: 2065490
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1