MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM SHORT AO PILOT DRILL; PLATE, FIXATION, BONE

Model Number 71631123

Device Problem Material Deformation (2976)

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

Event Date 06/21/2021

Event Type  malfunction  

Event Description

It was reported that during an arthroscopy, the tip of a 4.0mm short ao pilot drill was found deformed.It is unknown if a backup device was available.There was a delay greater than 30 mins reported during surgery.No other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review found related failures for the listed batch; 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.This is a single use device, 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: 4.0MM SHORT AO PILOT DRILL
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12112171
• MDR Text Key: 260096792
• Report Number: 1020279-2021-05651
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010497475
• UDI-Public: 03596010497475
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71631123
• Device Catalogue Number: 71631123
• Device Lot Number: 20LSZ0118
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1