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

Catalog Number UNKNOWN

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 01/31/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, seven (7) months after internal fixation surgery was conducted to repair a right peritrochanteric femur fracture, there was a subtrochanteric non-union with failed fixation for removal of deep broken right femur hardware.

Manufacturer Narrative

H10: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The end of the device is missing paint and broken, rendering the device inoperative.The clinical/medical evaluation concluded that this complaint was reported via medwatch.However, neither the requested relevant clinical information nor the device was provided.Therefore, a thorough medical investigation cannot be rendered nor could a definitive clinical root cause of the reported failure be determined.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.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, or injury.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.Internal complaint reference number: (b)(4).

• Brand Name: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL
• 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: 13935759
• MDR Text Key: 288175064
• Report Number: 1020279-2022-01387
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 04/22/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 97 KG