MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VLP MINI-MOD 1.1MM DRILL MINI QC; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 74461500

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/19/2021

Event Type  malfunction  

Event Description

It was reported that, during a trauma surgery, two (2) vlp mini-mod 1.1mm drill mini qc were bent.The instruments were outside of the patient.The procedure was successfully completed without delay using a smith and nephew back up device.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Damage from misuse or rough handling are likely probable causes of the reported event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: VLP MINI-MOD 1.1MM DRILL MINI QC
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11803374
• MDR Text Key: 249970260
• Report Number: 1020279-2021-03952
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00885556484296
• UDI-Public: 00885556484296
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 74461500
• Device Catalogue Number: 74461500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1