MAUDE Adverse Event Report: UNKNOWN EVOS PLATING SCREW; SCREW, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Failure to Align (2522)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2020

Event Type  malfunction  

Event Description

It was reported that in evos wrist sst procedure locking screw 2.4mm did not lock in the distal part of the plate.Delay less than 30 minutes, no impact to the patient known for the delay.No injury reported.The procedure was finished using the original device.Surgery was initially completed successful.(but without locking of screws).

Manufacturer Narrative

H3, h6: it was reported that during procedure 3 of 5 locking screws did not lock in the distal part of the plate.The procedure was completed successful using the original device.Delay was less than 30 minutes, no impact to the patient known for the delay.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Some potential causes could include but are not limited to surgical technique, screw head, plate tabs or instruments used.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: UNKNOWN EVOS PLATING SCREW
• Type of Device: SCREW, FIXATION, BONE
• MDR Report Key: 10558356
• MDR Text Key: 207698084
• Report Number: 1020279-2020-04735
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1