MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 13MM X 38CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71649838
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).Note - during the scheduled device revision on (b)(6) 2023, it was not possible to remove the implants.This complication was reported to fda under manufacturer report number 1020279-2023-02276 (documented in our eqms under complaint # (b)(4)).
Event or Problem Description
It was reported that, after undergoing internal fixation surgery on (b)(6) 2021 in which a meta-tan nail was placed, the outcome was deemed unsuccessful: the fracture did not heal together as expected.This adverse event was treated by scheduling a revision surgery on (b)(6) 2023.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, based on the limited documentation provided, the reported non-union led to the revision but there is insufficient information to conclude contributing factors to the bony non-union as patient medical history, comorbidities, activity level and surgical details are unknown.The failed attempts at the lag screw removal contributed to the significant surgical delay.Although no patient injury was reported due to the surgical extension, prolonged anesthesia/surgical delay is associated with an increased risk of complications to the patient.The patient impact included the reported unexpected outcome of fracture non-union, the incomplete revision procedure with an extended surgical delay due to the failed extraction attempts/lodged lag screw/nail, the re-scheduled procedure, and a prolonged period to heal is also possible.It was communicated that the surgeon was satisfied with the second attempt/revision outcome, however the current patient status is unknown.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 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 reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include procedural/user error, surgical complication or patient medical history.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 13MM X 38CM 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: 18172435
• Report Number: 1020279-2023-02277
• Device Sequence Number: 7793091
• Product Code: HSB
• UDI-Device Identifier: 00885556341940
• UDI-Public: 00885556341940
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 04/13/2026
• Device Catalogue Number: 71649838
• Device Lot Number: 16DM11622
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/14/2023
• Date Device Manufactured: 04/15/2016
• 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: MTTN LG/CMP KIT90/85(PN:71642690,LN:18BT99412)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown