MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

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

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

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Du, s.C., wang, x.H., & chang, s.M.(2021).The pre-loaded set-screw in intertan nail: should it be tightened or not tightened in pertrochanteric hip fractures.Geriatric orthopaedic surgery & rehabilitation, 12, 2151459321990640.Doi: 10.1177/2151459321990640.

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 sixth month postop and the patient complained from pain.A revision surgery has not been performed yet, and it was not reported if it will be needed in the future.It was not reported how the adverse event was treated.The outcome of the patient is unknown.No further information is available.

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the article noted one patient had fracture non-union at 6 months post-op and the patient complained of pain.The article indicated that a revision surgery had not been performed yet, and it was not reported if it will be needed in the future.Responses to the information request attempts and patient specific clinically relevant documentation had not been received as of the date of this medical investigation.The images provided in the article have been interpreted within the text and do not appear to belong to this case; therefore, no further analysis of the images is required.The clinical root cause of the reported non-union at 6 months cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products 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 devices 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 products involved, our investigation could not proceed.Should the devices 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 META-TAN TROCH 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 ; 5123913905
• MDR Report Key: 14279526
• MDR Text Key: 290662816
• Report Number: 1020279-2022-02078
• 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: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• 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): Other; Hospitalization