MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX36CM 125D LT; NAIL, FIXATION, BONE

Catalog Number 71676555

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, during the removal of an internal fixation, the screws could be explanted without any problem; however, the intertan 1.5 11.5mmx36cm 125d lt was found to be fractured while explanting it.It was only possible to explant the proximal part of the nail, the distal part remained inside intramedullary canal and without the possibility of being removed in the same surgery as the necessary instruments were not available.The procedure was finished after a delay greater than 30 minutes.Also, the surgeon decided to prolong the patient hospitalization to verify the fracture consolidation.The patient health status was reported as stable.

Event Description

It was reported that, a surgery was scheduled due to the pain that the patient reported, during the removal of an internal fixation, the screws could be explanted without any problem; however, the intertan 1.5 11.5mmx36cm 125d lt was found to be fractured while explanting it.It was only possible to explant the proximal part of the nail, the distal part remained inside intramedullary canal and without the possibility of being removed in the same surgery as the necessary instruments were not available.The procedure was finished after a delay greater than 30 minutes.Also, the surgeon decided to prolong the patient hospitalization to verify the fracture consolidation.The patient health status was reported as stable.

Manufacturer Narrative

H10: additional information h2: updated section b5, and h6 (clinical code and impact code).

Manufacturer Narrative

H2: additional information ¿h6: health effect - clinical code¿.H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the intertan nail fractured in half.Only one piece was returned.The visual also reveals nails were returned with signs of wear.The im nail fractured by the initiation and subsequent propagation of fatigue cracking.The fatigue cracking eventually propagated to an extent that the remaining cross-sectional area of the nail could not bear the imposed patient loading, which led to an overload fracture.Fatigue cracking was likely caused by the nail bearing cyclic stresses more than the material endurance limit for an extended period of time.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels prior to full bone union, applications of loads in excess of the material¿s strength, and/or poor bone quality.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.The clinical/medical evaluation concluded that in the absence of the requested clinical documentation, the root cause of the breakage could not be definitely concluded.However, we cannot rule out persistent fracture, early weight bearing, and trauma as factors which could lead to the reported nail breakage.The lack of the necessary instruments to remove the nail in its entirety led to the retention of the distal portion of the nail.Since the distal portion of the nail remains unfixed within the medullary canal, the potential for micro-motion and/or migration cannot be ruled out.Biocompatibility is not an issue as the nail is composed of biocompatible material, titanium alloy, that is intended for implantation.The impact to the patient includes the pain, prolonged additional surgery and hospitalization.The patient will undergo an additional surgery to remove the distal part of the nail and it is unknown the future impact beyond this.No further clinical assessment could be rendered 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management and information for use files revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A review of instructions for use for intramedullary nail system revealed in possible adverse effects that cracking or fracture of the implant may occur.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.Overweight or musculoskeletal deficient or unhealthy patients may create greater loads on implants that may lead to breakage or other failure of the implants.Additionally, postoperative care section warns that early weight bearing substantially increases implant loading and increases the risk of breaking the device.According with inspection drawing, the final inspection includes the verification of part configuration per print.Also, per material specification, shall control the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 11.5MMX36CM 125D LT
• 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: 18033207
• MDR Text Key: 326880244
• Report Number: 1020279-2023-02095
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K210980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71676555
• Device Lot Number: 17FT88743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG