MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN DIS FEM WDG TRL 10MM SZ 3; PROST, KNEE, FEMTIB, SEMI-CONSTRAINED, CEMENTED, M/P

Model Number 71431658

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

It was reported that, during a tka surgery, the screw in the back of a lgn dis fem wdg trl 10mm sz 3 fell out.The screw is not supposed to come out of wedge trial at all.The screw did not fall inside the patient.The surgery was completed, without any delay, with a s+n back-up device.No injuries were reported.

Manufacturer Narrative

Initial mdr.Internal complaint reference: case(b)(4).

Manufacturer Narrative

D4: lot# and expiration date.D10: device available for evaluation? h4: device manufacture date.Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirms the trail screw came apart from the device.Both pieces were returned.The device shows signs of significant wear and use.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it can no longer fit its purpose, the contribution of the device to the reported event could be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Misassembling after reprocessing or rough handling are potential factors that may have contributed to the reported event.Additionally we recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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 future complaints and investigate as necessary.We consider this investigation closed.E1: name and address.

• Brand Name: LGN DIS FEM WDG TRL 10MM SZ 3
• Type of Device: PROST, KNEE, FEMTIB, SEMI-CONSTRAINED, CEMENTED, M/P
• 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: 15863454
• MDR Text Key: 307794179
• Report Number: 1020279-2022-04811
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010545558
• UDI-Public: 03596010545558
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71431658
• Device Catalogue Number: 71431658
• Device Lot Number: 11CSM0130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1