MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 18CM 125D; NAIL, FIXATION, BONE

Catalog Number	71675383
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during proximal femur surgery, one (1) intertan 10s 10mm x 18cm 125d was going to be used in an operation but it was not sterile.The package was open in one end.The procedure was performed, without any delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the product was not returned for evaluation; therefore, a product analysis could not be performed.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.The provided photographs were reviewed, and revealed that the packaging bag is unsealed.However, according with the packaging sequence, the bag should not be sealed.The unsealed bag (containing the product inside) is placed inside the inner tray and then, the inner tray lid is sealed to inner tray.The inner tray is then placed in the outer tray and the outer lid is sealed to outer tray.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.No defects were found on the provided photographs, therefore no factors that can contribute the reported event can be delineated.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.Corrected data: h6 (medical device problem code).

• Brand Name: INTERTAN 10S 10MM 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: 19546855
• Report Number: 1020279-2024-01159
• Device Sequence Number: 6711843
• Product Code: JDS
• UDI-Device Identifier: 00885556105696
• UDI-Public: 00885556105696
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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 Catalogue Number: 71675383
• Device Lot Number: 23KM08871
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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