MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7MM INF DIST CLAV PL 3H R 81MM; PLATE, FIXATION, BONE

Model Number 72468803

Device Problems Defective Device (2588); Material Deformation (2976)

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

Event Date 04/12/2021

Event Type  Injury  

Event Description

It was reported that during an internal fixation surgery, it was noticed that the 2.7x3 hole inferior distal clavicle plate was over contoured distally and wouldn't fit the patient.No patient injury was reported.There was no significant delay and the procedure was finished using a competitor's device.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed device.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as fit/sizing of the device used.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: EVOS 2.7MM INF DIST CLAV PL 3H R 81MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11781904
• MDR Text Key: 249224178
• Report Number: 1020279-2021-03802
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556666173
• UDI-Public: 00885556666173
• Combination Product (y/n): N
• PMA/PMN Number: K173293
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72468803
• Device Catalogue Number: 72468803
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/06/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention