MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 100/95; NAIL, FIXATION, BONE

Model Number 71677100

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case (b)(4).

Event Description

It was reported that, after an intertan surgery had been performed on (b)(6) 2021, the patient experienced pain post surgery.The x-rays showed backing out of the compression screw used with an intertan device which was locked with the set screw.Also, the surgical team are still deciding on appropriate treatment for the patient.It is unknown how the adverse event was solved and current health status of patient.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation, but the pictures were reviewed, and the failure mode was confirmed.The clinical/medical investigation concluded that per the complaint, three chart-stixs of the implants used, and the two x-rays were provided that reveal the backing out of the compression screw used with an intertan device which was locked with the set screw.However, no relevant clinical information or the device were provided, therefore, a thorough medical investigation cannot be rendered nor can a root cause of the reported failure be determined.According to the complaint, the surgical team is still deciding on the appropriate treatment for the patient.It is unknown how the adverse event was solved and current health status of patient.Therefore, the impact to the patient beyond that which has already been reported is unknown.Should any additional relevant patient information be provided this complaint would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use was performed.In the preoperative planning section, a proper type and size of implant must be selected to insure effective treatment of patients.Furthermore, loosening is identified as a potential adverse effect.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to traumatic injury, surgical technique, size of device, joint tightness, material in use, patient reaction and/or patient condition.The contribution of the device to the reported event could be corroborated as the backing out of the compression has been confirmed.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: LAG/COMP SCREW KIT 100/95
• Type of Device: NAIL, 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: 12953291
• MDR Text Key: 281865029
• Report Number: 1020279-2021-08544
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010563323
• UDI-Public: 03596010563323
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71677100
• Device Catalogue Number: 71677100
• Device Lot Number: 21CT47979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2021
• 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
• Patient Outcome(s): Required Intervention