MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL; NAIL, FIXATION, BONE, METALLIC

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: yapici, f., üçpunar, h., gür, v., onaç, o., alpay, y., karaköse, r., & çamurcu, y.(2022).Functional and radiological comparison of three cephalomedullary nails with different designs used in the treatment of unstable intertrochanteric femur fractures of elderly.Yaslilarda instabil intertrokanterik femur kiriklarinin tedavisinde kullanilan dizaynlari farkli üç sefalomedüller çivinin fonksiyonel ve radyolojik açidan karsilastirilmasi.Ulusal travma ve acil cerrahi dergisi = turkish journal of trauma & emergency surgery : tjtes, 28(5), 668¿677.Https://doi.Org/10.14744/tjtes.2020.80733.

Event Description

On the on the literature review "functional and radiological comparison of three cephalomedullary nails with different designs used in the treatment of unstable intertrochanteric femur fractures of elderly", it was reported that, after undergoing a primary internal fixation with an intertan nailing system, one (1) patient suffered from deep vein thrombosis.It is unknown how this issue was solved.The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H10: additional information in b5.H11: corrected information in h6 (health effect - impact code).

Event Description

On the on the literature review "functional and radiological comparison of three cephalomedullary nails with different designs used in the treatment of unstable intertrochanteric femur fractures of elderly", it was reported that, after undergoing a primary internal fixation with an intertan nailing system, one (1) patient suffered from deep vein thrombosis.This patient first used coumadin and enoxaparin for the first 2 weeks, then continued to use coumadin for 6 months with an inr level between 2.5 and 3, and finally recovered uneventfully at the end of the 6th month.No further information is available.

Manufacturer Narrative

H3, h6: given the nature of the alleged incident, the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports, in a literature review, 1 patient suffered from deep vein thrombosis, after having a primary internal fixation with an intertan nailing system.This patient first used coumadin and enoxaparin for the first 2 weeks, then continued to use coumadin for 6 months, and finally recovered uneventfully at the end of the 6th month.No further information is available.Without clinical documentation and patient specific information, a thorough medical investigation cannot be performed.The clinical root cause of the deep vein thrombosis is a procedural complication not a product failure.The patient¿s outcome/impact was newly reported as ¿finally recovered uneventfully at the end of the 6th month.¿ no further information is available.No further medical assessment is warranted at this time at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.The contribution of the device to the reported event could not be corroborated.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 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: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL
• Type of Device: NAIL, FIXATION, BONE, METALLIC
• 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: 15236950
• MDR Text Key: 298006128
• Report Number: 1020279-2022-03671
• Device Sequence Number: 1
• Product Code: NDH
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention