MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 9MM X 36CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71649536
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Discomfort (2330); Nonunion/Delayed-union Bone Fracture (2369); Joint Laxity (4526); Unspecified Tissue Injury (4559)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered from a mechanical complication of the nail after having a fracture fixation surgery of the left femur using the trigen meta-tan system.There is instability of the distal segment of the femur with lateral displacement relative to nail and its previous position.The distal segment appears unstable and mobile, causing significant pain and discomfort.The patient underwent a revision surgery to address the issue.It is unknown if the patient achieved union.The current state of health of the patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
Additional Manufacturer Narrative
Internal reference number: (b)(4).This complaint was opened by smith+nephew to document a patient complication identified through a review of clinical evidence from a post market clinical follow up activity sponsored by smith and nephew.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Additional information: d10, h6 (health effect - clinical code and medical device problem code).
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the devices could not be returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the information provided, we cannot rule out the displaced bone fragments, inadequate fracture reduction, lack of skeletal support structures and the high-impact trauma, as the likely causes of the reported non-union, and the subsequent revision.However, a persistent nonunion or the time between the initial finding of backing out of the 2 distal screws which was noted on x-ray prior to the scheduled revision cannot be ruled out as a contributing factor to the patient¿s pain, bone movement, discomfort and lucency.Nor can we rule out the patient¿s mental history and a non-compliance with weightbearing restrictions as prescribed.Therefore, it could not be concluded that these adverse events were a mal performance of the implant or an implant failure.Further patient impact beyond the reported pain, screw backing out, instability, discomfort and the subsequent revision could not be determined since the patient health status is unknown.For the nail, the device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the screws, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the nail, a review of complaint history for the previous 12 months did not reveal similar events for the listed device.For the screws, 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 instructions for use documents for intramedullary nail system revealed that care prior to bony union stablish to immobilize and/or externally support skeletal structures that have been implanted with surgical metallic implants until skeletal union is observed.Early weight bearing substantially increases implant loading and increases the risk of loosening, bending or breaking the device.Early weight bearing should only be considered where there are stable fractures with good bone-to-bone contact.Patients who are obese and/or noncompliant, as well as patients who could be pre-disposed to delayed or non-union, should have auxiliary support.The implant may be exchanged for a larger, stronger nail subsequent to the management of soft tissue injuries.Patients and nursing care providers should be advertised of these risks.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.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 for future complaints and investigate as necessary.We consider this investigation closed.Corrected data: b3, b5, b7, h6 (health effect - clinical code).
Event or Problem Description
It was reported that the patient suffered from a mechanical complication of the nail after having a fracture fixation surgery of the left femur using the trigen meta-tan system on (b)(6)2020.The patient she had not being taking pain medications or blood thinner.Approximately two weeks later on (b)(6)2020, that the patient presented to the clinic due to increase in pain, swelling, and movement of the bones at the fracture site.An analysis of an x-ray dated (b)(6)2020 showed that the distal segment of the femur has lateral displacement relative to the nail and its anterior position.Additionally, peri-articular lucency has been noted in the 3 distal interlocking screw and the 2 most distal screws have backed out.On (b)(6)2020 the patient had a revision surgery to treat this issue.The surgeon used a s&n supplemental lateral plate, along with three additional distal locking screws, and two non-locking screws through the plate and around the nail.Post implantation x-ray showed a post revision of the anterior portion of the comminuted left distal femur fracture which appears to be sufficient reduction and a good alignment of nail of the portion that is seen as well as the addition of the s&n supplemental lateral plate.The distal femur which was unstable in the previous fixation is not visible in the post-revision image.Consequently, it is unknown if the patient achieved union.The current state of health of the patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.

• Brand Name: META-TAN 9MM X 36CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 16015672
• Report Number: 1020279-2022-04997
• Device Sequence Number: 7340650
• Product Code: HSB
• UDI-Device Identifier: 00885556338599
• UDI-Public: 00885556338599
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2024

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: 71649536
• Device Catalogue Number: 71649536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 08/22/2024; 10/09/2024
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 08/22/2024; 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6)/TRIGEN LOW PROFILE SCREW 5.0MM X 37.5MM.; (B)(6)/TRIGEN LOW PROFILE SCREW 5.0MM X 40MM.; (B)(6)/TRIGEN LOW PROFILE SCREW 5.0MM X 42.5MM.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female