MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRAUMA & EXTREMITIES DEV

Catalog Number UNKN02000000

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).

Event Description

It was reported that a patient had an intertan nail previously implanted, but this had failed.On (b)(6)-2021, had a revision.The patient is morbidly obese, and on opening was showing infection markers.The surgeon sent aspirate away for culture and rebuilt the neck using fibula allograft.He reamed to 13mm and a 13mm nail was mistakenly chosen (11.5mm was the intended size).He realized this when inserting nail, and back slapped the nail.At this stage the gig disconnected and fell on the floor, which caused a delay while this was re-sterilized (part of the instrument was re-sterilized, not the device.Delay of approximately 2 hours).The procedure was completed with the correct nail, lag and compression screws inserted and locked with the set screw.The intertan nail has failed again, with the lag screw backing out again even though it was locked.Further revision surgery plan is unsure at this stage.No further information will be available.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.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 are not limited to user error, sizing issue and/or patient condition.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.

• Brand Name: UNKN TRAUMA & EXTREMITIES DEV
• Type of Device: UNKN TRAUMA & EXTREMITIES DEV
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12475947
• MDR Text Key: 271632508
• Report Number: 1020279-2021-06887
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN02000000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention