MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 38CM; NAIL, FIXATION, BONE

Model Number 71655138

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during internal fixation surgery, a 3.0mm guide rod became incarcerated in a trigen meta tibial nail 10mm x 38cm.In order to complete the procedure, both the nail and guide rod were removed and replaced.Surgery was resumed after a delay greater than 30 min.Patient was not injured as consequence of this problem.

Manufacturer Narrative

H6: the associated device was returned and evaluated.The visual inspection revealed that the device has scratches and damaged along its surface as well as a foreign material along the tip of the device.A lab analysis performed on the device revealed the 3.0mm guide rod was not returned for investigation purposes.However, a functional audit using another 3.0mm guide rod was performed in attempt to recreate the nail incarceration, the nail was able to slide over the guide rod as intended without jamming occurring.Further investigation would require the original guide rod to be returned.No manufacturing or material deviations were found during the investigation.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over 12 months and for the batch number based on historical data of the device 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 historical review concluded that there are no prior actions related to this product and event.According with the inspection procedure, the final inspection includes the verification of part configuration per print.A review made by the quality engineering team revealed that per the pin gage checks, the implant was within print specification.The functional check contained dropping a plus pin gage from the distal end down towards proximal end, ranging from 163 -196 until the pin couldn't go any further.Then checking at the proximal end of the implant.Since the mating part 3.0mm x 1000mm ball tip guide wasn't sent in, the evaluation of the instrument could not be conducted.It is clear that the largest diameter of the cannulation was more than adequate to accept the acceptance of the ball tip guide.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or insertion technique.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: META-NAIL TIBIAL 10MM X 38CM
• 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: 15135800
• MDR Text Key: 303054455
• Report Number: 1020279-2022-03530
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010585608
• UDI-Public: 03596010585608
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K061019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71655138
• Device Catalogue Number: 71655138
• Device Lot Number: 21MSM0129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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 INSTR