MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA INTERFACE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 71692802

Device Problem Output Problem (3005)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/12/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a femur & tibia internal fixation locking is done for the retrograde nail and it is well positioned.However, the trauma interface did not display the measurement sign for the locking pin.Monitor pointers were not static, so anything that could be generating interference was removed and the signal improved.Then, when placing the tibia nail and performing the locking, calibration was performed by sending the guide to full, resulting in 36 of length.After this, it is repositioned to the length of the one selected (320mm) and the channel is drilled, again the console did not measure the axial channel to verify the length of the lock.However, from the control panel of the console, before removing the drill bit, the drilling results were verified and no error in the measurement field were found.This was a 29.8 mm measurement.Nonetheless, this was measured with a conventional meter and the trauma interface advanced to verify the locking, resulting in 35/2 almost reaching the 34 line, the length of the bolt was verified with a measurement also verified with a this got verified with the and the length of the bolt is verified with a meter.For the second lock, from medial to lateral, surgeon had some difficulty with the measurement so she decided to take x-rays and verify if it was inside the canal and when verifying with the trauma interfac, the measurement was about 33/2, almost reaching 32, the locking was placed so the surgeon proceeded with the proximal locking of the nail, when finishing placing all the material, a correct positioning of the bolts was verified under rays, the 3rd bolt towards the proximal, was noticed to be poorly positioned.Surgeon decided to change the locking to the ap and performed it freehand with a drill and hammer.Under an intensifier image a good positioning was evident corroborated several times.However, the morning after, when the final image was received, it became evident that both distal locking bolts were left outside the nail.A second intervention will be needed.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation stated that the request clinical information was not provided for evaluation.Therefore, there were no clinical factors identified which would have contributed to the reported event.The impact to the patient includes the reported non-significant surgical delay and the anticipated additional surgical procedure.No further clinical assessment is warranted at this time.Device serial 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.A review of the instructions for use documents for trigen¿ sureshot¿ distal targeting system revealed that a field accuracy check procedure should be performed at least once a year or whenever the accuracy of a trigen¿ sureshot¿ probe or trigen sureshot targeter needs to be verified.This procedure can also be performed during surgery to verify all components are working correctly prior to their use on a patient.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.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, a broken wire in the targeter cable, bent pins in the connector or an open circuit on the data line 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 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: TRAUMA INTERFACE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 18298519
• MDR Text Key: 330112020
• Report Number: 1020279-2023-02454
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 03596010648174
• UDI-Public: 3596010648174
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K170280
• 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
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71692802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 80 KG