MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 85/80; NAIL, FIXATION, BONE

Model Number	71677085
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal reference number: case (b)(4).
Event or Problem Description
It was reported that, after an internal fixation surgery was performed on (b)(6) 2021, an intertan 11.5mm x 20cm 125d nail failed due to a cut out and the lag/comp screws were backing out despite being locked in the case.This adverse event was solved by a revision surgery performed on (b)(6) 2021.Patients current health status is unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The images provided were reviewed and the migration was confirmed.The clinical/medical investigation concluded that, this case reports that post-operative x-rays revealed that lag/ compression screw backed out of the intertan nail.It was communicated via e-mail that a revision surgery has not been performed for the patient.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinically relevant information have not been provided.X-ray photo examples were provided via e-mail; these x-ray images are not directly from this case, but encompass the issue observed in other similar complaint cases that have been already lodged.The x-ray examples provided demonstrate the lag screw and compression screw have backed out.Based on the limited information provided the clinical root cause of the report issue could not be determined.The provided example images were reviewed and confirm the reported however, they are examples from multiple subjects, so a specific root cause could not be concluded.The initial placement of the lag and compression screws within the femoral head, reduction and stability of the fracture, or user technique and cannot be ruled out as contributing factors of the reported screws backing out.The intertan nail is implantable; however, we cannot rule out the potential risk of irritation, discomfort, inflammation, pain, micro-motion, and/or migration of the screws.No further clinical/medical assessment is warranted at this time.A review of the complaint history did not reveal additional complaints for the listed batch.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 the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as surgical technique, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.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.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.The images provided were reviewed and the migration was confirmed.The clinical/medical investigation concluded that, this case reports that one month following implantation of the intertan system a revision surgery was performed due to the screws backing out despite being locked in the case.X-ray photo examples were provided via e-mail; these x-ray images are not directly from this case, but encompass the issue observed in other similar complaint cases that have been already lodged.The x-ray examples provided demonstrate the lag screw and compression screw have backed out.The provided customer feedback form noted that of the intertan nails implanted ¿almost all are done by trainees, and non-trainee registrars.¿ the current health of the patient is unknown.Based on the limited information provided the clinical root cause of the report issue could not be determined.The provided example images were reviewed and confirm the reported however, they are examples from multiple subjects, so a specific root cause could not be concluded.The initial placement of the lag and compression screws within the femoral head, reduction and stability of the fracture, or user technique and cannot be ruled out as contributing factors of the reported screws backing out.The patient impact beyond the report revision could not be determined.No further clinical/medical assessment is warranted at this time.A review of the complaint history did not reveal additional complaints for the listed batch.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 the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as surgical technique, bone degeneration, fit/sizing, lack of ingrowth and/or traumatic injury.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: LAG/COMP SCREW KIT 85/80
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; brooks rd. 1450; memphis TN
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 12430954
• Report Number: 1020279-2021-06741
• Device Sequence Number: 17483058
• Product Code: JDS
• UDI-Device Identifier: 03596010563293
• UDI-Public: 03596010563293
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71677085
• Device Catalogue Number: 71677085
• Device Lot Number: 19GT24298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 11/15/2021
• Initial Report FDA Received Date: 09/06/2021
• Supplement Report FDA Received Date: 10/13/2021; 11/16/2021
• Date Device Manufactured: 07/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown