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

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

Patient Problems Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369)

Event Date 02/11/2021

Event Type  Injury  

Event Description

It was reported that on literature review "the pre-loaded set-screw in intertan nail: should it be tightened or not tightened in pertrochanteric hip fractures", one patient had an adverse event after being operated with an intertan nail fixation system due to a pertrochanteric hip fracture caused by a fall from standing.The patient's fracture was not healed at the fourth month postop and coronal ct reconstruction showed non-union.Sclerotic change was seen at the fracture site.As there was pain in activities of daily life, the patient finally underwent revision fixation by reverse liss plate at 10 months postop.The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, 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 and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury,procedural/user error, surgical/post operative complications, healing issues 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 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.

• Brand Name: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL
• 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
• MDR Report Key: 14279677
• MDR Text Key: 290662542
• Report Number: 1020279-2022-02067
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female