MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE

Model Number	71675202
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an internal fixation procedure, when beginning to make the drilling for the placement of the intertan 11.5mm x 18cm 125d.It was started with the lateral cortical drill however, when passing the next drill it felt that did not allow to insert easily, therefore a lot force was used as consequence of the resistance.The drill was able to be inserted.After, the anti-rotational guide was placed and began to insert the next drill, however, happened the same thing where there was a lot of resistance.Surgeon chose not to place the kit screw but rather a single screw.The kit screw had already been screwed in and decided to remove the internal locking screw from the nail, after several attempts and trying very hard, it was possible to make the last drill hole and place the kit screw.Nonetheless, internal block of the nail could not be made, apparently it was out of adjustment and could not be done, of which the doctor was very aware and decided to leave it that way.Surgery was performed after a non-significant delay, with the same device.Patient's current health status is stable.
Additional Manufacturer Narrative
Section h3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, without supporting documentation, clinical factors have not been confirmed which would have contributed to the reported event.The surgical technique does provide guidance of t-handles for proper lag screw alignment with the pre-assembled cannulated set screw, as well as recommendations if encountering hard bone or resistance with instrumentation but cannot confirm if these were factors.The patient impact included the reported additional ¿surgical time and anesthetics¿ due to resistance and difficulty drilling, as well as the modified surgical procedure with removal of the internal locking screw with repeated attempts to place the kit screw and unplanned outcome of the ¿internal block of the nail cannot be made¿.The patient status was reportedly stable.Further patient impact could not be determined.No further medical assessment can be rendered at this time.Based on the information provided, the unsatisfactory experience could be confirmed.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.A review of the instructions for use documents for intramedullary nail system revealed in preoperative planning that proper placement of implants are necessary to effectively treat patients using metallic surgical implants.Besides, a proper type and size of implant must be selected to ensure effective treatment of patients.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.Factors that could contribute to the reported event include procedural/user error, surgical complication, size selected and/or insertion technique.Based on this investigation, the need for corrective action is not indicated.Should 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: INTERTAN 11.5MM X 18CM 125D
• 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: 16759055
• Report Number: 1020279-2023-00857
• Device Sequence Number: 14183107
• Product Code: JDS
• UDI-Device Identifier: 03596010561053
• UDI-Public: 03596010561053
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: 71675202
• Device Catalogue Number: 71675202
• Device Lot Number: 22JT67759
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown