MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 8.5MM X 33CM; NAIL, FIXATION, BONE

Model Number	71655033
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during trauma surgery, the medullary canal had been previously rimmed and one (1) meta-nail tibial 8.5mm x 33cm was placed, an attempt was made to block distally with sureshot and under fluoroscopy but it was not possible to place the screw after several attempts.The procedure was resumed, after a non-significant delay, using a different size s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H6: health effect - impact code.Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported failure.According to the report, the surgeon decided to change to another device of a different size and completed the surgery with a non-significant delay.Per report, the patient¿s health was not affected.Therefore, the impact to the patient beyond that which has already been reported, cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.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.A proper type and size of implant must be selected to insure 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 size selected or insertion technique.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: META-NAIL TIBIAL 8.5MM X 33CM
• 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: 16748735
• Report Number: 1020279-2023-00843
• Device Sequence Number: 20964467
• Product Code: JDS
• UDI-Device Identifier: 03596010585486
• UDI-Public: 03596010585486
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 71655033
• Device Catalogue Number: 71655033
• Device Lot Number: 21MM07946
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/16/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: Male