MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED SCREW 90MM 6.5; PLATE, FIXATION, BONE

Model Number 121638

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, following an internal fixation surgery performed on an unspecified date to treat a femoral fracture with large cannulated screws, the patient sustained a screw prominence and pain that required an additional surgery to remove this hardware.A specific date for this procedure was not provided, and additional details regarding the clinical course of the patient remain also unknown.No further information is available.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The data was collected from the post-market clinical follow up activity (pmcf) was anonymous, no further information will be provided.Consequently, without the requested clinical information, a thorough clinical assessment cannot be performed at this time.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded based on the information provided.Therefore, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for fracture fixation devices, compression hip screws, cannulated/bone screws, bone plates, pins, wires revealed that screw cutting through the femoral head (usually associated with osteoporotic bone), penetration of the joint by a lag screw with or without chrondrolysis, and failure of a lag screw to slide in the barrel, especially with low angle plates and/or improper screw plate assembly have been reported.Postoperative instructions to patients and appropriate nursing care are critical.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 reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, alignment, size selected, procedural/user error, traumatic injury, joint tightness, patient condition/anatomy, postoperative care and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.Internal complaint reference number: (b)(4).

Manufacturer Narrative

Additional information has been received and was assessed by the manufacturer.A correction in the previously provided narrative has been made.Corrected data: b5 (narrative updated to include post-op time of additional surgery & patient's most recent health status).

Event Description

It was reported that, following an internal fixation surgery performed on an unspecified date to treat a femoral fracture with large cannulated screws, the patient sustained a screw prominence and pain that required an additional surgery to remove this hardware at twenty (20) months postoperatively.A specific date for this procedure was not provided.It has been reported that the patient has had no issues or reoperations since this removal surgery.No further information is available.

Manufacturer Narrative

Updated results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The data was collected from the post-market clinical follow up activity (pmcf) was anonymous, no further information will be provided.Consequently, without the requested clinical information, a thorough clinical assessment cannot be performed at this time.It was reported the screws were removed from the patient at 20 months for prominence and the patient has had no issues or re-operations since the report.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for fracture fixation devices, compression hip screws, cannulated/bone screws, bone plates, pins, wires revealed that screw cutting through the femoral head (usually associated with osteoporotic bone), penetration of the joint by a lag screw with or without chrondrolysis, and failure of a lag screw to slide in the barrel, especially with low angle plates and/or improper screw plate assembly have been reported.Postoperative instructions to patients and appropriate nursing care are critical.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 reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include abnormal loading of limb, alignment, size selected, procedural/user error, traumatic injury, joint tightness, patient condition/anatomy, postoperative care and/or traumatic injury.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: CANNULATED SCREW 90MM 6.5
• 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: 15665571
• MDR Text Key: 302333925
• Report Number: 1020279-2022-04546
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010063939
• UDI-Public: 03596010063939
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K993106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 121638
• Device Catalogue Number: 121638
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization