MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 30CM 125D LEFT; NAIL, FIXATION, BONE

Catalog Number 71675505

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 07/13/2023

Event Type  Injury  

Event Description

It was reported that, after a trauma surgery had been performed on (b)(6) 2023, an intertan 10s 10mm x 30cm 125d left suffered a breakage.The nail broke at lag/compression screw hole, and the reason is unknown.A revision surgery was performed on (b)(6) 2023 to address this adverse event.Current health status of patient is unknown.

Manufacturer Narrative

Internal complaint reference: case(b)(4).

Manufacturer Narrative

H3, h6: the reported event was analyzed.Although the involvement of all the devices was reported, the relationship with the investigated failure was directly associated to the intertan 10s 10mm x 30cm 125d left.Therefore, no investigation is deemed for the other devices.The device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that, per the complaint details, approximately five months after a trauma surgery, the patient experienced a nail breakage.Reportedly, the nail broke at lag/compression screw hole, and the reason is unknown.According to the report, the patient underwent a revision to address this adverse event.However, without the requested relevant supporting medical documentation, there were no clinical factors found which could have caused or contributed to the reported adverse events.Since the status of the patient is unknown, the patient impact beyond the reported nail breakage and subsequent revision cannot be determined based on the limited information provided.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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 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.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.Verifying the device configuration according to the inspection drawing is performed within the steps of the final inspection.Besides, according to the material specification, the quality and manufacture of standard grade titanium-aluminum-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, abnormal loading of limb, excessive forces and/or traumatic injury.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.

Manufacturer Narrative

H10: h3, h6: the associated devices were returned and evaluated.A visual inspection of the returned device reveals the intertan nail fractured into two pieces.The visual also reveals signs of wear on the returned screws.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 per the complaint details, approximately five months after a trauma surgery, this patient experienced a nail breakage.Reportedly, the nail broke at lag/compression screw hole, and the reason is unknown.According to the report, the patient underwent a revision to address this adverse event.However, without the requested relevant supporting medical documentation, there were no clinical factors found which could have caused or contributed to the reported adverse events.Since the status of the patient is unknown, the patient impact beyond the reported nail breakage and subsequent revision cannot be determined based on the limited information provided.Therefore, no further clinical/medical assessment can be rendered at this time.Should any additional relevant medical information be provided, this case would be re-assessed.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, the quality and manufacture of standard grade titanium-6 aluminum-4 vanadium alloy shall be controlled.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 10S 10MM X 30CM 125D LEFT
• 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: 17394070
• MDR Text Key: 319740093
• Report Number: 1020279-2023-01497
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040212
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71675505
• Device Lot Number: 21EM18030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PN: 71645027 / LOT: 22FM22643.; PN: 71677090 / LOT: 21GT52287.; PN: 76515310 / LOT: UNKNOWN.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female