MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 9MM X 32CM RIGHT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71640532
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).Health effect - clinical code h6: e2127 periprosthetic fracture.
Event or Problem Description
It was reported that after an internal fixation surgery performed on (b)(6)2019, the patient was playing hockey when he was hit by another player and sustained a periprosthetic fracture of his right distal femur.To address this event adverse the patient underwent removal of the retained hardware and open reduction internal fixation utilizing an intramedullary nail on (b)(6)2024.After the procedure, the patient was taken to the pacu in satisfactory conditions.
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the images provided, the periprosthetic fracture led to the revision; however, the initial implant selection/appropriateness cannot be ruled out as a potential contributing factor to the periprosthetic fracture due the revision to a longer nail.The patient impact included the periprosthetic fracture and the subsequent revision to a longer nail.Further impact could not be determined based on the information provided.No further medical assessment can be rendered at this time.Factors that could contribute to the reported event include the patient¿s history of non ossifying fibroma, alignment, size selected, patient anatomy, procedural/user error and/or the traumatic injury.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed in the preoperative planning section states that proper type and size of implant must be selected to ensure effective treatment of patients considering factors such as patient¿s size, strength, skeletal characteristics, skeletal health, and general health.The correct surgical technique is essential to a successful outcome.Proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.Additionally, the postoperative care section reveals that the implant may be exchanged for a larger, stronger nail subsequent to the management of soft tissue injuries.Also, the notes section states that healing of fractures treated with metallic surgical implants must be confirmed prior to permitting weight bearing on the bones.Weight bearing on bones that have failed to heal or healed partially or improperly can cause stress and fatigue in metallic surgical implants.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 this products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: META-TAN 9MM X 32CM RIGHT
• 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: 20102944
• Report Number: 1020279-2024-01683
• Device Sequence Number: 12847171
• Product Code: HSB
• UDI-Device Identifier: 00885556339046
• UDI-Public: 885556339046
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2026
• Device Catalogue Number: 71640532
• Device Lot Number: 16BT65304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2016
• 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: META-TAN 0MM SET SCREW, LOT#:21EM19413; META-TAN COMPRESSION SCREW 35MM:LOT#19AT15080; META-TAN LAG/COMP KIT 70/65, LOT:19BT16887; TRIGEN LOW PROFILE SCREW 5.0MM X 30MM, LOT#:21KM13
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male