MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 2.7MM INF DIST CLAV PL 7H L 109MM; PLATE, FIXATION, BONE

Model Number 72468707N

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, during fracture fixation surgery, a plate with locking holes were selected to provide more stability; however, the evos 2.7mm inf dist clav pl 7h l 109mm was not machined properly and had no threads in the holes.This resulted in the screws being unable to lock into the plate.Surgery was resumed, after a non-significant delay, with a smith and nephew back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation.However, the photograph was reviewed, and revealed that the device had no threads in the holes.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that the failure mode was not detected at the inspection points during the manufacturing process which indicates 100% visual inspection of all holes throughout the operations.As mentioned by the quality engineering team, factors that could contribute to the reported event include machine variation, tools set up incorrectly, tool offsets incorrect, trunnion mal-function or machine axis off center.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 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.According to the drawing print, the holes of the device should have a 2.7mm thread detail.At this time, we do have reason to suspect that the product failed to meet specifications at the time of manufacture.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.

• Brand Name: EVOS 2.7MM INF DIST CLAV PL 7H L 109MM
• 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: 16808049
• MDR Text Key: 313930781
• Report Number: 1020279-2023-00922
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556666142
• UDI-Public: 00885556666142
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210837
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72468707N
• Device Catalogue Number: 72468707N
• Device Lot Number: 21DM06480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Date Device Manufactured: 04/09/2021
• 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