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

Catalog Number UNKNOWN

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

Patient Problem Limb Fracture (4518)

Event Date 07/23/2014

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).Lu, d.L., lv, x.J., li, b., & yang, d.X.(2014).Intertan compression interlocking intramedullary nail for femoral intertrochanteric fractures: clinical application and design advantages.Chinese journal of tissue engineering research, 18(31), 4957.Doi: 10.3969/j.Issn.2095-4344.2014.31.007.

Event Description

It was reported that, on literature review "intertan compression interlocking intramedullary nail for femoral intertrochanteric fractures: clinical application and design advantages", one (1) patient who initially underwent primary implantation with an intertan nail to treat a femoral intertrochanteric fracture experienced a refracture on an unspecified region of the femur six (6) months postoperatively.Any measures taken to resolve this periprosthetic fracture were not listed within the publication.No further information is available.

Manufacturer Narrative

The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the requested clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.Therefore, no further interpretation of the attached images is required.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 potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.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 ; 5123913905
• MDR Report Key: 14808224
• MDR Text Key: 294863232
• Report Number: 1020279-2022-03100
• 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: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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: 07/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL SCREW
• Patient Outcome(s): Other