MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX40CM 125D RT; NAIL, FIXATION, BONE

Catalog Number 71676560

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Osteomyelitis (4533); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2021

Event Type  Death  

Event Description

It was reported that an unknown trigen intertan nail fractured.It remains unknown when this problem was noticed and whether a case or patient was involved or not.

Manufacturer Narrative

Internal reference number: (b)(4).Internal reference number: (b)(4).

Event Description

It was reported that, after an internal fixation surgery had been performed on (b)(6) 2019 to treat a fracture in the per- and sub-trochanteric region, the patient experienced a fracture of the intertan 1.5 11.5mmx40cm 125d rt, nonunion of fractures, pseudoarthrosis, mechanical complication on the tight and a chronic osteomyelitis of the pelvic region and the proximal femur caused by staphylococcus infection.An additional surgery was performed on (b)(6) 2021 to treat this adverse event.The fractured intertan 1.5 11.5mmx40cm 125d rt was removed, and antibiotic spacers were placed in a resected proximal femoral region.An additional revision was planned to be performed 3 to 4 days after this intervention to treat the media infection cavity and to resect minor trochanter ossifications, although it is unknown if this procedure was indeed performed.The patient passed away on (b)(6) 2021 due to a sepsis by staphylococcus aureus with aortic valve endocarditis.

Manufacturer Narrative

H6: the device, intended for use in treatment, was not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury or surgical technique.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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

Results of investigation: the associated device was returned and evaluated.From the analysis conducted during this investigation, it was concluded that the intertan 1.5 11.5mmx40cm nail fractured by the initiation and subsequent propagation of fatigue cracking.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels during the reported non-union of the bone, applications of loads in excess of the material¿s strength, and/or poor bone quality.No manufacturing or material deviations were found during this investigation.A review of complaint history revealed one event for the listed part number over the previous 17 months, where only an infection occurred.Other similar events related to the nonunion and fracture of the device where not found.The review did not real similar events for the batch based on the historical data.These failure modes will be monitored for future complaints for any necessary corrective actions.A review of the sterilization records revealed the batch was sterilized within normal parameters.The clinical/medical evaluation concluded that based on the information provided, and the femoral fracture at the time of the revision it cannot be concluded the root cause of the broken nail, but the noted infection cannot be ruled out as a contributing factor affecting the support of the nail.The patient passed away on 19-jul-2021 due to sepsis by staphylococcus aureus with aortic valve endocarditis.Based solely on the information provided, a causal relationship between the s&n device and the reported death cannot be confirmed but it was communicated with the complaint, ¿we have no indications that the death of the patient is in any way related to the reported nail fracture.We were informed of the patient's death in relation to the declaration of consent of the patient, which is mandatory in germany for an investigation of the explants.¿ no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint 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 file and instructions for use document revealed these failure modes were 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 modes.A contribution of the device to the reported fracture could be corroborated as the device shows signs of damage, however a contribution of the device to the reported infection could not be corroborated.Possible causes could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb, contamination, patient reaction or post operative healing issue.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.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.From the analysis conducted during this investigation, it was concluded that the intertan 1.5 11.5mmx40cm nail fractured by the initiation and subsequent propagation of fatigue cracking.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.These excessive cyclic stresses may be caused by any number of conditions, including but not limited to excessive patient activity levels during the reported non-union of the bone, applications of loads in excess of the material¿s strength, and/or poor bone quality.No manufacturing or material deviations were found during this investigation.A review of complaint history revealed one event for the listed part over the previous 17 months, where only an infection occurred.Other similar events related to the nonunion and fracture of the device where not found.The review did not real similar events for the batch based on the historical data.These failure modes will be monitored for future complaints for any necessary corrective actions.A review of the sterilization records revealed the batch was sterilized and the product received the indicated dose within the precision and accuracy of the dosimetry system employed (by co-60 gamma-irradiation).The clinical/medical evaluation concluded that based on the information provided, and the femoral fracture at the time of the revision it cannot be concluded the root cause of the broken nail, but the noted infection cannot be ruled out as a contributing factor affecting the support of the nail.Should any additional relevant medical information be provided, this complaint 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 file and instructions for use document revealed these failure modes were 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 modes.A contribution of the device to the reported fracture could be corroborated as the device shows signs of damage, however a contribution of the device to the reported infection could not be corroborated.Possible causes could include but not limited to traumatic injury, patient anatomy, abnormal loading of limb, contamination, patient reaction or post-operative healing issue.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 11.5MMX40CM 125D RT
• 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: 12368629
• MDR Text Key: 268211130
• Report Number: 1020279-2021-06532
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/10/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71676560
• Device Lot Number: 19FT23121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 10/06/2021; 11/26/2021; 03/22/2022; 05/27/2022
• Supplement Dates FDA Received: 10/05/2021; 12/10/2021; 04/07/2022; 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2019
• 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
• Treatment: LAG/COMP SCREW KIT 95/90 / 71677095; TRIGEN LOW PROFILE SCREW 5.0MM X 40MM / 71645040; TRIGEN LOW PROFILE SCREW 5.0MM X 47.5MM / 71645047
• Patient Outcome(s): Death
• Patient Age: 82 YR