MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN EVOS PLATING SCREW; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 09/22/2020

Event Type  Injury  

Event Description

It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis, patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.Revision surgery was performed to correct the problem.X-rays attached.

Manufacturer Narrative

It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis, patient had pain after 14 days, and x-ray revealed that all 5 lateral screws (1 cortex and 4 locking), had loosened and lay outside the plate and just beneath the skin.A revision surgery was performed to correct the problem.The affected complaint device, used in treatment, was returned and evaluated.A visual inspection of the returned device shows no obvious signs of damage on the part.A dimensional analysis noted that all measurable device features are within specifications.Features checked include threads, and head thread and diameters of the head and shafted.As batch information was not available on the device, therefore the manufacturing records review could not be conducted.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 complaint history on the listed part revealed no prior complaints for the listed failure mode.A review of the risk management files and instructions for use revealed that this failure mode has been identified.A relationship between the device and the reported incident or adverse event could be corroborated.A medical analysis noted that without the requested relevant clinical information, primary and revision report, trauma history, physical activity or the device the root cause of the reported loosening cannot be determined.Technique error of the prep or selection for the screws cannot be ruled out as well the quality of the bone cannot be concluded which could also play a factor in this failure.Based on the limited information provided, the impact to the patient beyond the revision cannot be determined.Therefore, no further clinical/medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew 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: UNKN EVOS PLATING SCREW
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10738054
• MDR Text Key: 213149270
• Report Number: 1020279-2020-05769
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1