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

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 10/10/2023

Event Type  Injury  

Event Description

It was reported that, during an internal fixation surgery, a 2.0mm unknown evos plating screw was inserted into a mid shaft ulna and upon inserting the screw on power to finish seating with hand tightening the head of the screw broke off.The broken piece was removed, but the rest of the broken screw was left inside the patient.It is unknown if there were any delays to the surgery due to this issue, but the procedure was completed using evos mini 2.4 mm screws.No patient injury was reported due to this issue.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the devices sent by the costumer were returned and evaluated.Although the screws provided were not directly involved in the complaint case, similar screws in terms of size and specification were provided.A review made by the quality engineering team revealed that, upon investigation, it was discovered that all six parts provided by the sales representative were within the tolerance outlined in the drawing print.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported breakage could not be determined.Although a procedure vs user error could not be rule out as a contributory factor.The evos screws are made of 318 stainless steel, and they are used to fix the plate to the bone, inside the patient.According to the report, the body of the screw was left secured in the patient's bone, therefore, the possibility of micro-motion and/or migration is unlikely.The surgeon completed the procedure with a evos mini 2.4mm screw in a new bone hole without any injury to the patient, however, it is unclear if there was a delay in the procedure.The impact to the patient was the retained screw.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the instructions for use documents for evos plating system revealed that loosening, bending, cracking or fracture of implant components has been identified in the adverse effects.Device specific identifiers were not provided.Therefore, an evaluation of the manufacturing records, complaint history review, risk management file, prior actions and product prints could not be performed.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique and/or user error.Based on this investigation, the need for corrective action is not indicated.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.Corrected data: h6 (health effect - impact code).

• Brand Name: UNKNOWN EVOS PLATING SCREW
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18737789
• MDR Text Key: 335736231
• Report Number: 1020279-2024-00403
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/08/2024
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR