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

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Perforation (2001)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Zhao, f., guo, l., wang, x., & zhang, y.(2021).Benefit of lag screw placement by a single-or two-screw nailing system in elderly patients with ao/ota 31-a2 trochanteric fractures.Journal of international medical research, 49(3), 03000605211003766.Doi: 10.1177/03000605211003766.

Event Description

It was reported that on literature review "benefit of lag screw placement by a single- or two-screw nailing system in elderly patients with ao/ota 31-a2 trochanteric fractures", after a trochantic fracture was treated with an intertan nail, four patients had screw cutouts.It was not reported how the adverse event was resolved.The outcome of the patients are 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 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; therefore, no further analysis of the images is required.The clinical root cause of the reported screw cutouts cannot not be further assessed.The patients¿ outcomes beyond that which was documented in the article cannot not be determined as the patients¿ 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 product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to bone degeneration, lack of ingrowth, surgical technique, size of device, patient anatomy, abnormal loading and/or traumatic injury.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 product 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 INTERTAN INTERTROCH ANTEGR NAIL SCREW
• 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: 14282046
• MDR Text Key: 290686256
• Report Number: 1020279-2022-02104
• 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: 05/26/2022

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: 05/25/2022
• 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
• Treatment: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL
• Patient Outcome(s): Other