MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 2.7MM DEPTH GAUGE SHORT; PLATE, FIXATION, BONE

Model Number 71175067

Device Problems Break (1069); Device Markings/Labelling Problem (2911)

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

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).

Event Description

It was reported that during case, blue tape was noticed to be missing completely to identify evos small 2.7mm depth gauge short and it has slowly chipped off while being use.No delay or injury occurred due to this event.It is unknown who the procedure was concluded.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that without the requested clinical information, radiographs, operative report or the device, the root cause of the reported issue cannot be determined.The possible retained paint chips are non-implantable; therefore, we cannot rule out the possibility of local skin irritation or micro-motion/migration of the retained paint chips.The impact to the patient beyond that which has been reported cannot be determined.Since it was reported the event completed with a competitor¿s device without delay or injury, no further clinical assessment is warranted at this time.A review of complaint history did not 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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: EVOS SMALL 2.7MM DEPTH GAUGE SHORT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11087495
• MDR Text Key: 224060906
• Report Number: 1020279-2020-07881
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556635858
• UDI-Public: 00885556635858
• Combination Product (y/n): N
• PMA/PMN Number: K162078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71175067
• Device Catalogue Number: 71175067
• Device Lot Number: 18KRS0026
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1