MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 36CM; NAIL, FIXATION, BONE

Catalog Number 71655136

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Event Description

It was reported that, after an internal fixation surgery performed on (b)(6) 2023, the patient indicated that on (b)(6) 2023 the meta-nail tibial 10mm x 36cm that was implanted broke in half.The surgeon who implanted the device drilled holes in it to secure it with more hardware, but it still broke.On (b)(6) 2023 a revision surgery was performed in order to replace the broken nail.The current health status of the patient is good.

Manufacturer Narrative

H10; additional information: updated section b5 and h6 (clinical code).

Event Description

It was reported that, after an internal fixation surgery performed on (b)(6) 2023, the patient indicated that on (b)(6) 2023 the meta-nail tibial 10mm x 36cm that was implanted broke in half casing pain and angulation of the site.The surgeon who implanted the device drilled holes in it to secure it with more hardware, but it still broke.On (b)(6) 2023 a revision surgery was performed in order to replace the broken nail.The current health status of the patient is good.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation.However, the photographs were reviewed, and revealed that the nail fractured into two pieces.The clinical/medical investigation concluded that, based on the information provided, it can be concluded that the reported meta-tan nail breakage is not indicative of a malperformance of the smith and nephew device.The customization of the implant (drilling additional holes for screw mid shaft) coupled with the patient¿s persistent fractures and reported activity are likely contributing factors to the reported event.The surgeon confirmed by reporting ¿additional risks for him are that he was putting a huge number of cycles walking on the nail and there was a segment that was slower than normal in consolidating.¿ instructions for use for fracture fixation devices, notes "use extreme care in handling and storing implant components.Cutting, bending, or scratching the surface of metal components can cause internal stresses which significantly reduce the strength and fatigue resistance.It was further reported per the surgeon " the nail broke before we would have expected complete healing either way.¿ the patient¿s current health status is reportedly ¿good.¿ the impact is the revision of this nail and extended rehabilitation.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number 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 cracking or fracture of the implant components have been identified in possible adverse effects section.A review of the risk management file 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 product and event.According with material specification, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, postoperative care, patient anatomy, abnormal loading of limb and/or excessive forces.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.We consider this investigation closed.H6: health effect - clinical code.

• Brand Name: META-NAIL TIBIAL 10MM X 36CM
• Type of Device: NAIL, FIXATION, BONE
• 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: 18267466
• MDR Text Key: 329734623
• Report Number: 1020279-2023-02378
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010585585
• UDI-Public: 03596010585585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71655136
• Device Lot Number: 21KT55678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 86 KG