MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 95/90; NAIL, FIXATION, BONE

Model Number	71677095
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after trauma surgery was performed on (b)(6) 2020, a post-operative x-ray revealed that the implanted trigen intertan nail screws 95mm / 90mm are backing out despite of being locked in the case.It is unknown how this adverse event was treated.No revision surgery was conducted.Patient's current health status unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode 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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.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 abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, lifetime of device, and/or traumatic injury.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.

• Brand Name: LAG/COMP SCREW KIT 95/90
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12394772
• Report Number: 1020279-2021-06628
• Device Sequence Number: 3576889
• Product Code: JDS
• UDI-Device Identifier: 03596010563316
• UDI-Public: 03596010563316
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 71677095
• Device Catalogue Number: 71677095
• Device Lot Number: 19GT23842
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention