MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 26CM 125D LEFT; NAIL, FIXATION, BONE

Model Number 71675501

Device Problems Failure to Align (2522); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2020

Event Type  Injury  

Event Description

It was reported that during surgery, while checking alignment for drilling the distal screw hole using a targeting device which was made in (b)(6) the drill interfered with the nail (around static hole).The nail was used and no return.Procedure was completed by free hands.Delay 60 minutes reported.Backup device not available.No injury or impact to patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the clinical information provided is insufficient to determine the root cause of device failure to align.Based on the information provided, the surgeon changed the procedure to a freehand technique.Per report, there was a 60-minute delay and a backup device was not available.Since there was, no injury or impact to the patient, no further clinical/medical assessment is warranted at this time a review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.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 surgical technique used, size of device or user/procedural variance.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: INTERTAN 10S 10MM X 26CM 125D LEFT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10551763
• MDR Text Key: 207494406
• Report Number: 1020279-2020-04654
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556343746
• UDI-Public: 00885556343746
• Combination Product (y/n): N
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71675501
• Device Catalogue Number: 71675501
• Device Lot Number: 20EM04773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention