MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM 1/3 TUBULAR PL 7H 82MM; PLATE, FIXATION, BONE

Catalog Number 72440807N

Device Problems Flaked (1246); Device Damaged by Another Device (2915)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  Injury  

Event Description

It was reported that after an ankle plate and screw procedure on (b)(6) 2023, the patient's wound was re-opened and the device technology tightrope ((b)(6) were removed, as well as debridement of metal fillings, on 04-dec-2014.The tightrope had been put through the plate when one (1) evos small 2.5mm drill w/ao qc short hit the side of the plate and metal fillings fell on the inside of the patient.It was suggested that it was user error in not drilling the tightrope square against the plate.Patients' current health status is unknown.

Manufacturer Narrative

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

Event Description

It was reported that after an ankle plate and screw procedure on (b)(6) 2023, the patient's wound was re-opened and the device technology tightrope (b)(6) was removed, as well as debridement of metal fillings, on (b)(6) 2014.The tightrope had been put through the evos 3.5mm 1/3 tubular pl 7h 82mm when a drill hit the side of the plate and metal fillings fell on the inside of the patient.It was mentioned that it was surgeon error because a competitor product was used with ours and the drill and plate for the tightrope had been the item to need debriding as the drill was used at an improper angle.Patients' current health status is unknown.

Manufacturer Narrative

H3, h6: although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the evos tubular plate.Given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that reportedly, the adverse event was due to a user technique/error while using a competitor product with smith and nephew products.The patient impact included the metallic debris reportedly created by the competitor drill (which appears to have made contact with the smith and nephew evos plate) along with the use of a competitor tightrope device, and unspecified debridement of the surgical wound.It was reported that all debris was debrided.Cannot conclude if noted damage to the plate will affect the strength and fatigue resistance of the plate.Although the complaint indicated the patient¿s wound was re-opened, the wound in the photo does not appear to have had a closure technique, but this cannot be confirmed.No delay or patient injury was reported due to this issue.Further patient impact could not be determined with the combination of competitor product and damage to the plate.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for evos plating system revealed in warnings section that it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of the device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.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 used or procedural/user error.Based on this investigation, the need for corrective action is not indicated.Should 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 3.5MM 1/3 TUBULAR PL 7H 82MM
• 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: 18395479
• MDR Text Key: 331358747
• Report Number: 1020279-2023-02602
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K210837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72440807N
• Device Lot Number: 21ET50765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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
• Treatment: 71175027/UNKNOWN/EVOS SMALL 3.5MM OVERDRILL W/AO Q; 72403511N/UNKNOWN/EVOS 3.5MM X 11MM CTX SCR S-T; 72403522N/UNKNOWN/EVOS 3.5MM X 22MM CTX SCR S-T; 72424710N/22EM03754/EVOS 4.7MM X 10MM OST SCR FT; EVOS 3.5MM 1/3 TUBULAR PL 7H 82MM, PN:72440807N; EVOS 3.5MM X 11MM CTX SCR S-T, PN:72403511N; EVOS 3.5MM X 22MM CTX SCR S-T, PN:72403522N; EVOS 4.7MM X 10MM OST SCR FT, PN:72424710N; EVOS SMALL 3.5MM OVERDRILL W/AO QC SHORT, PN:71175
• Patient Outcome(s): Hospitalization; Required Intervention