MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 85/80; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71642685

Device Problems Device Markings/Labelling Problem (2911); Unintended Movement (3026)

Patient Problems Respiratory Tract Infection (2420); Implant Pain (4561)

Event Date 04/10/2021

Event Type  Injury  

Event Description

It was reported that after trauma procedure for internal hip fixation, the patient had postoperative pain on the hip joint, copd exacerbation and lung infection.X-ray examination indicated good positioning of the implant.Two days after the procedure, it was discovered that trigen meta-tan troch antegr nail screws were use to fixate a trigen intertan intertroch antegr nail, causing the implant to be unstable.A revision surgery had to be performed in order to retrieve the wrong screws and insert the correct ones.Details about the surgery are unknown.No other complications were reported.

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, based on the information provided, ¿it was a human mistake,¿ that lead to the implantation of the wrong screws.An analysis of the provided x-rays showed the devices in place with the meta-tan screw.According to the report, the patient was revised to the correct size intertan screws.The impact to the patient beyond that which has already been reported cannot be determined.However, it has been communicated that although the patient is experiencing pain, she is ¿improving¿.No further medical assessment is warranted at this time.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 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 85/80
• 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11815676
• MDR Text Key: 250323557
• Report Number: 1020279-2021-04118
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556132982
• UDI-Public: 00885556132982
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71642685
• Device Catalogue Number: 71642685
• Device Lot Number: 18LT12507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention