MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 37CM; NAIL, FIXATION, BONE

Model Number	71655137
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation but the pictures were reviewed, and revealed the presence of an unintended particle in the nail.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 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 product specifications at the time of manufacture.Factor that could contribute to the reported event include but not limited to a grindstone jammed in the device during the surface finishing process.The contribution of the device to the reported event could be corroborated since the photos confirm the presence of an unintended particle in the nail.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.Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery, a rock was found within the meta-nail tibial 10mm x 37cm when opened.It is unknown how surgery was finished and if it was delayed; however, patient harm was not indicated.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation but the pictures were reviewed and revealed the presence of an unintended particle in the nail.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 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 do have evidence to suspect that the product failed to meet any product specifications at the time of manufacture.An investigation made by the quality engineering team revealed that worn grinding stones changed too late could be a factor for the unintended particle in the nail.With the results of this investigation the root cause of this event could not be determined.However, certain process specifications may not have been followed in the manufacturing process.Based on this investigation, the need for corrective actions is indicated.Inspection plans and standard rework process are going to be improve in the manufacturing process.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 10MM X 37CM
• 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: 16043354
• Report Number: 1020279-2022-05030
• Device Sequence Number: 20160312
• Product Code: JDS
• UDI-Device Identifier: 03596010585592
• UDI-Public: 03596010585592
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71655137
• Device Catalogue Number: 71655137
• Device Lot Number: 21FT51953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2021
• 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
• Patient Sex: Unknown