MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STERILE 6.4MM DRILL; DRILL, BONE, POWERED

Model Number 71631035

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2020

Event Type  malfunction  

Event Description

It was reported that during arthroscopy (acl or other) while instrument was outside the patient the sterile 6.4mm drill broke.Delay reported less or equal than 30 minutes.It is unknown how was the procedure completed.No report of patient injury or harm was received.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: STERILE 6.4MM DRILL
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10657178
• MDR Text Key: 211848778
• Report Number: 1020279-2020-05305
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 03596010605962
• UDI-Public: 03596010605962
• Combination Product (y/n): N
• PMA/PMN Number: K123055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71631035
• Device Catalogue Number: 71631035
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1