MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 8.5MM X 32CM; NAIL, FIXATION, BONE

Catalog Number	71655032
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation, when going to place the distal screws of the meta-nail tibial 8.5mm x 32cm with the sureshot, the drill touched the nail.After several tries, they moved the probe to the calibration of a 33cm (8.2x33) nail and it worked correctly.The surgeon suspects a packaging problem, inside the box there was actually an 8.5x33 nail instead of an 8.5x32, as the box and label say.The material will not be returned since it has been implanted at patient.The surgery was completed after a significant delay.No injuries were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: given the nature of the alleged incident, the device could not be returned for evaluation; therefore, a device analysis could not be performed.The photographs were reviewed and revealed an unknown measuring instrument that shows a measurement of 33 (no units shown).However, this picture does not show the reported device nor discloses how the device is being measured.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review made by the quality engineering team revealed that the production analysis data showed that there were no nail orders of length 32 cm or 33 cm at one workstation in production at the same time.Investigation results indicate that there is no evidence of a product defect or manufacturing issue.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.According to the drawing print, the device size should be 32 centimeters of length.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.As there is no evidence of a product defect or manufacturing issue, the factors that could have contributed to the reported event include surgical technique used or user/procedural variance.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.
Event or Problem Description
It was reported that, during an internal fixation, when going to place the distal screws of the meta-nail tibial 8.5mm x 32cm with the sureshot, the drill touched the nail.After several tries, they moved the probe to the calibration of a 33cm (8.2x33) nail and it worked correctly.The surgeon suspects a packaging problem, inside the box there was actually an 8.5x33 nail instead of an 8.5x32, as the box and label say.The material will not be returned since it has been implanted at patient.The surgery was completed after a significant delay.The surgical result was good, but the surgeon was not satisfied with the extra time in the surgery to be able to place the distal screws.The current health status of the patient is good.No injuries were reported.

• Brand Name: META-NAIL TIBIAL 8.5MM X 32CM
• 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: 17796603
• Report Number: 1020279-2023-01811
• Device Sequence Number: 17829879
• Product Code: JDS
• UDI-Device Identifier: 03596010585462
• UDI-Public: 03596010585462
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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 Expiration Date: 11/09/2025
• Device Catalogue Number: 71655032
• Device Lot Number: 15LT61320
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• 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 Age: 41 YR
• Patient Sex: Male