MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 100/95; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71642600

Device Problem Use of Device Problem (1670)

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

Event Date 05/24/2020

Event Type  Injury  

Event Description

It was reported metatan screws has been used in a intertan nail.The problem was discovered during post op x-ray.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint from sweden reports that metatan screws were implanted with an intertan nail.The or-staff complained - regarding our packages since they look very similar.This is a package problem.Reportedly, it is also hard to read the packages because the plastic cover (¿welding¿) lays direct over the text.A revision surgery was performed to remove the metatan screw and replace with the correct intertan screw.The problem was discovered during a post-operative x-ray.Smith and nephew has not received the device or adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Impact to the patient beyond the second surgery cannot be determined.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 risk management files and instructions for use found that the reported failure was documented appropriately.The potential probable cause for this event is likely off label use.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

Manufacturer Narrative

Results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The contribution of the device to the reported event could not be corroborated.The clinical/medical investigation concluded that, this complaint from sweden reports that metatan screws were implanted with an intertan nail.The or-staff complained - regarding our packages since they look very similar.This is a package problem.Reportedly, it is also hard to read the packages because the plastic cover (¿welding¿) lays direct over the text.A revision surgery was performed to remove the metatan screw and replace with the correct intertan screw.The problem was discovered during a post-operative x-ray.Smith and nephew has not received the device or adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.Impact to the patient beyond the second surgery cannot be determined.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A complaint history review did not find related failures for the part number in scope.However, due to the nature of the failure mode, review was expanded for the metatan screws product family, and similar events were identified.This failure mode will be monitored for future complaints for any necessary corrective actions a review of the label specification for meta-tan and for intertan was conducted and it revealed the information regarding the product, such as part number, name, and size, was found to be clear, legible, and complete in both labels.A review of the work instructions revealed that the procedure for the shrink-wrapping operation is explained in detail to ensure the correct application.Also, a review of the packaging inspection procedure was conducted, and it revealed the labels are verified under shrink wrap to ensure visibility.A review of the risk management files revealed that this failure mode and associated harm has been identified and the anticipated risk level is still adequate.The product meets the specifications at the time of manufacture.Possible causes could include but not limited to user error.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-TAN LAG/COMP KIT 100/95
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 10171898
• MDR Text Key: 195718904
• Report Number: 1020279-2020-02565
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71642600
• Device Lot Number: 19BT16884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other