MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 20CM 125D; NAIL, FIXATION, BONE

Model Number	71675205
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an internal fixation surgery, performed on (b)(6) 2021, screws of meta-tan lag/comp kit 100/95 ((b)(4)) were used through an intertan 11.5mm x 20cm 125d ((b)(4)), leading to early implant failure.With some further investigation, it was discovered that there was no sales rep present at the original operation, and the error was made by a junior clinician at point of surgery.The surgeon and hospital do not blame the implants at all, and the metatan screws have now been more clearly labelled for future reference.This issue was resolved with a revision performed on (b)(6) 2021.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this represents a procedure complication and does not represent a device malfunction.Based on the information provided, the error was made by a junior clinician at point of surgery.According to the report, the metatan screws have now been clearly labelled, the surgeon does not blame the implants and the issue was resolved with a revision.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this complaint will be re-assessed.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable cause could include but not limited to procedural variance or user error.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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: INTERTAN 11.5MM X 20CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12105179
• Report Number: 1020279-2021-05619
• Device Sequence Number: 3774936
• Product Code: JDS
• UDI-Device Identifier: 03596010565389
• UDI-Public: 03596010565389
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 71675205
• Device Catalogue Number: 71675205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention