MAUDE Adverse Event Report: SMITH & NEPHEW, INC. THICK ITALIAN NUT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 71070286

Device Problem Material Deformation (2976)

Patient Problem Perforation (2001)

Event Date 11/21/2023

Event Type  Injury  

Event Description

It was reported that, during an external fixation surgery, a difference between the metal strength of a thick italian nut and the 10mm wrenches was noticed; or that the 10mm wrench might be slightly too large for the nut.This resulted in deforming the nuts upon tightening, and burring the wrenches.As a consequence, a wrench 10mm flex head was stricken with a mallet, which inadvertently maligned the frame.All the fixation (4 ha pins) had to be removed and restarted, adding at least 1 hour to the procedure and additional holes and incisions to the bone had to be performed.Current health status of the patient is unknown.

Manufacturer Narrative

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

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation.However, the photograph was reviewed, and revealed that the thick italian nut is deformed.The clinical/medical investigation concluded that, based on the information provided, the visual inspection of the image provided confirmed the thick italian nut was deformed, however, it does not indicate a root cause.According to the report, the surgeon use of the mallet to strike the wrench 10mm flex head, caused the malignment of the frame.The impact to the patient beyond the surgical delay of approximately one hour, the additional bone holes and the incisions to the bone cannot be determined since the current health status of the patient is unknown.Therefore, no further clinical/medical assessment is warranted at this time.For the thick italian nut, the device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.For the wrench and the wrench flex head, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the thick italian nut, a review of complaint history of 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.For the wrench, a review of complaint history revealed a similar event for the listed device over 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the wrench flex head, 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.For the thick italian nut, a review of the instructions for use documents for care, maintenance, cleaning, and sterilization of smith & nephew orthopedics devices for single-use devices revealed that the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.Reuse may increase the risk of breakage, failure, patient infection, patient injury and revision surgery.For the wrench and the wrench flex head, a review of the instructions for use documents for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.A review of the risk management files 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.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.The thick italian nut, is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.The wrench and the wrench flex head, are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

Manufacturer Narrative

The thick italian nut was not returned for evaluation.However, the photograph provided by the customer was reviewed, and revealed that the thick italian nut is deformed.A visual inspection of the returned wrenches reveal a few scratches and burrs on the connecting end of both wrenches.The device shows signs of normal wear and use.This inspection was conducted by naked eye.A functional evaluation performed could not be completed due to the thick italian nut was not returned to test with the wrenches.The clinical/medical investigation concluded that, based on the information provided, it is confirmed that the nut was deformed, however, it does not indicate a root cause.According to the report, the surgeon use of the mallet to strike the wrench 10mm flex head, caused the malignment of the frame.The impact to the patient beyond the surgical delay of approximately one hour, the additional bone holes and the incisions to the bone cannot be determined since the current health status of the patient is unknown.Therefore, no further clinical/medical assessment is warranted at this time.For the thick italian nut, the device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for care, maintenance, cleaning, and sterilization of smith & nephew orthopedics devices for single-use devices revealed that the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.Reuse may increase the risk of breakage, failure, patient infection, patient injury and revision surgery.For the wrench and the wrench flex head, a review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Also, a review of the instructions for use documents for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.For the wrench, a review of complaint history revealed a similar event for the listed device over 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.For the wrench flex head, 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 files 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.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.The thick italian nut, is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.The wrench and the wrench flex head, are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the thick italian nut 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: THICK ITALIAN NUT
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 18331872
• MDR Text Key: 330547548
• Report Number: 1020279-2023-02504
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 00885556119372
• UDI-Public: 00885556119372
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71070286
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 02/05/2024; 04/03/2024
• Supplement Dates FDA Received: 02/06/2024; 04/09/2024
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 71075900/21ESC0034/WRENCH 10MM X 13MM; 71075907/22HSC0018/WRENCH 10MM FLEX HEAD
• Patient Outcome(s): Other