MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN HUMERAL NAIL IMPLANT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNKNOWN

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

Patient Problem Necrosis (1971)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Cite: fan, w., cui, x., shi, l., xie, t., rui, y., & chen, h.(2022).Comparison of locking plate and intramedullary nail in treatment of neer two-and three-part fractures of the proximal humerus in the elderly.Zhongguo xiu fu chong jian wai ke za zhi= zhongguo xiufu chongjian waike zazhi= chinese journal of reparative and reconstructive surgery, 36(3), 274-278.Doi: 10.7507/1002-1892.202107003.

Event Description

It was reported that on literature review "comparison of locking plate and intramedullary nail in treatment of neer two and three-part fractures of the proximal humerus in the elderly", one (1) patient experienced a case of avascular necrosis of the humeral head after an intramedullary nail procedure using a proximal humerus trigen intramedullary nail.It is unknown how this adverse event was treated.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, per the complaint details, no further information will be provided.Consequently, 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.Some potential probable causes that could contribute to the reported event have been identified as patient reaction, 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 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: TRIGEN HUMERAL NAIL IMPLANT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15115153
• MDR Text Key: 296716926
• Report Number: 1020279-2022-03497
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 08/23/2022
• 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: UNKNOWN TRIGEN HUMERAL NAIL SCREW
• Patient Outcome(s): Other