MAUDE Adverse Event Report: SMITH & NEPHEW, INC. D-RAD TI 2.4MM X 12MM CTX SCR T7 S-T; PLATE, FIXATION, BONE

Model Number	74682412
Medical Device Problem Code	Device Contaminated at the User Facility (4064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, d-rad ti 2.4mm x 12mm ctx scr t7 s-t was contaminated when opening the container.It is unknown whether the event happened during surgery and if there was patient involvement.
Additional Manufacturer Narrative
Additional information: b4.
Event or Problem Description
It was reported that, during a trauma surgery while the instrument was outside of the patient, the d-rad ti 2.4mm x 12mm ctx scr t7 s-t was contaminated when opening the container.The procedure was successfully completed with no significant delay using a smith and nephew back up device.Patient was not harmed.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to user/procedural 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: D-RAD TI 2.4MM X 12MM CTX SCR T7 S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11803370
• Report Number: 1020279-2021-03948
• Device Sequence Number: 14430620
• Product Code: HRS
• UDI-Device Identifier: 00885556394748
• UDI-Public: 00885556394748
• Combination Product (Y/N): N
• PMA/510(K) Number: K132296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2021

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: 74682412
• Device Catalogue Number: 74682412
• Device Lot Number: 20CM01970
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 09/16/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/11/2021; 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1