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 Problems Arthritis (1723); Failure of Implant (1924); Pain (1994); Joint Laxity (4526)

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.

Manufacturer Narrative

It was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis.The 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 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 review of risk management files found that the reported failure was documented appropriately.A medical analysis noted that two undated, unlabeled x-rays confirmed the stated failure.However, 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 as it could 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 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.We consider this investigation closed.

Manufacturer Narrative

H3, h6: it was reported that the patient was operated with the evos clavicle plate and screws, for an pseudo arthrosis.The 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 for evaluation.A visual inspection of the returned device could not confirm the stated failure mode.The device was inadvertently lost.The attached pictures of the device showed signs of damage from attempted use.Based off the evaluation of the plate and other screws , we have no reason to suspect this device contributed to the failure.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 medical analysis noted that two undated, unlabeled x-rays confirmed the stated failure.However, 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 as it could 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.Some potential probable causes for this event could include poor bone quality, a traumatic event or over-tightening of the screws.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 the device or additional information be received, the complaint will be reopened.We consider this investigation closed.G1 mdr reporting contact name and address.

• 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: 10738115
• MDR Text Key: 213152980
• Report Number: 1020279-2020-05775
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2021

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?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention