MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAY; TRAY, SURGICAL, INSTRUMENT

Model Number	71070490
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was dried blood on the tray and hardware, even though it was sterilised upon arrival from loan.The case abandoned mid surgery due to contamination risk.It is unknown whether the surgery was rescheduled or not.Patient outcome is also unknown.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation but the pictures were reviewed, and the issue was confirmed.A review of complaint history did not reveal additional complaints for the listed devices.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.For cleaning procedures please refer to smith and nephew¿s recommended cleaning methods given in our cleaning and sterilization brochure-¿instructions for care, maintenance, cleaning and sterilization of smith & nephew orthopedic devices¿.The document is available from customer service or via the smith and nephew website, which suggests using a surgical scrub brush to remove visible debris.Possible causes could include but not limited to instructions not followed correctly, reprocessing error during cleaning/sterilization.Based on this investigation, the need for corrective action is not indicated.Should the devices 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: TRAY
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11086844
• Report Number: 1020279-2020-07864
• Device Sequence Number: 14280573
• Product Code: FSM
• UDI-Device Identifier: 03596010462350
• UDI-Public: 03596010462350
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71070490
• Device Catalogue Number: 71070490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 09/17/2021
• 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: Other