MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL CAP 10MM; NAIL, FIXATION, BONE

Model Number 71634010

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2021

Event Type  Injury  

Event Description

It was reported that, at the end of the trauma procedure, the nail cap 10mm was placed on the patient, but this device never entered.It was well dissected and the entry of the nail was observed and it was entered with good direction, but it was rolled and it rolled and did not enter.After several attempts it was not possible to place the cap so it was rolled, it was evidenced in the irregular lines.Device inside the patient.The procedure was completed using a s+n back-up device.Surgery was greater than 30mins delayed.Patient was not harmed.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The threads of the device are stripped and damaged, rendering the device inoperative.The threads of the device may have been the reason the device kept rolling but did not progress.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.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.Should 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: NAIL CAP 10MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11942340
• MDR Text Key: 254369759
• Report Number: 1020279-2021-05008
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010495723
• UDI-Public: 03596010495723
• Combination Product (y/n): N
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71634010
• Device Catalogue Number: 71634010
• Device Lot Number: 17KM17329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR