MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 11.5MM X 39CM; NAIL, FIXATION, BONE

Model Number 71655239

Device Problem Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 06/06/2022

Event Type  Injury  

Event Description

It was reported that, after a meta-nail tibial 11.5mm x 39cm had been implanted on an unspecified date, the patient started experiencing pain.A revision surgery was performed on (b)(6) 2022 while attempting to remove the nail, the nail cap was jammed to the nail and it could not be removed.The procedure lasted 6 hours until the nail was removed by ordinary methods.Patient has been discharged from the hospital and is currently doing fine.

Manufacturer Narrative

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

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 clinical information, a thorough medical investigation cannot be rendered, nor could a definitive root cause of the reported failure be determined.Based on the information provided, the patient was revised due to pain.Per subsequent e-mail, it was reported, ¿the problem was in the tibial nail cap, it was like it sealed itself to the nail.¿ subsequently, it was reported the procedure lasted for 6 hours until the nail was removed by ordinary methods.According to the report, the patient is doing fine and discharged home.Since there was no harm has been alleged to this patient due to the prolonged use of anesthesia, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be a review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A review of the instructions for use for this device reveal in the preoperative planning/surgical technique section, that correct surgical technique is essential to a successful outcome.This section also mentions to review the surgical technique for effective surgical procedures.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes could be alignment, fit/size of device used or wear.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: META-NAIL TIBIAL 11.5MM X 39CM
• 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: 14830993
• MDR Text Key: 294871970
• Report Number: 1020279-2022-03122
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010585707
• UDI-Public: 03596010585707
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K061019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71655239
• Device Catalogue Number: 71655239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• 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: META-NAIL NAIL CAP SET SCREW 0MM
• Patient Outcome(s): Required Intervention; Hospitalization