MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 3.5MM DEPTH GAUGE LONG; PLATE, FIXATION, BONE

Model Number 71175068

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

It was reported during the procedure, that the tip of the depth gauge was broken outside the patient.The procedure was completed without delay with a backup from smith & nephew.No patient injury or other complications were reported.

Manufacturer Narrative

The device, intended for use in treatment was returned for evaluation: a visual inspection of the returned device confirmed the stated failure mode.The tip of the device is heavily damaged.A review of complaint history did reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: EVOS SMALL 3.5MM DEPTH GAUGE LONG
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10778167
• MDR Text Key: 214332870
• Report Number: 1020279-2020-06064
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556635865
• UDI-Public: 00885556635865
• Combination Product (y/n): N
• PMA/PMN Number: K162078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71175068
• Device Catalogue Number: 71175068
• Device Lot Number: 18KRS0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1