MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 35CM; NAIL, FIXATION, BONE

Model Number	71655135
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a trauma surgery a semi-extended technique was performed, starting with channel rhyme, using the semiextended entry tube with the clamping handle.The surgeon proceeded to insert the meta-nail tibial 10mm x 35cm manually, then he strongly impacted it with the hammer impactor and it was found that the handle was released from the guide.The surgeon was informed and he said that at the end he would removed it.Sales rep suggested to check before continuing and if possible remove the nail a little to know why the handle came loose and why the guide was being introduced, but the surgeon ignored it and repeated that after inserting the nail he would check.Each time it was evident that the guide did not touch the patellar region, sales rep showed him what happened at the end of impacting the nail to its point, the specialist noticed that the guide entered the medullary canal and its removal was not so easy, he hit the arc of connection of the semiextended drill guide, where the nail was attached to try to remove it, sales rep showed him that carefully because the blows with the hammer were on the legs that make connection with the black guide of proximal blocks, sales rep showed that one of them was crushed more than normal.Different tricks were performed to internally remove the semiextended drill guide, which did not move with the impacts.Finally, the nail connection was made and the nail was removed.The procedure was resumed, after a significant delay, with a s+n back-up nail and an infrapatellar technique.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The devices were not returned for evaluation; therefore, a device analysis could not be performed.For the meta-nail tibial 10mm x 35cm, 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 the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.For the semiextended drill guide, the device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.For both devices, 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 these products and event.Based on the information provided, the event could be confirmed.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should the devices 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 10MM X 35CM
• Common Device Name: 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: 16854451
• Report Number: 1020279-2023-00953
• Device Sequence Number: 7566386
• Product Code: JDS
• UDI-Device Identifier: 03596010585578
• UDI-Public: 03596010585578
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71655135
• Device Catalogue Number: 71655135
• Device Lot Number: 22DT62450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 90 KG