MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAY ACUFEX DIRECTOR ELITE; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number	72201731
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an acl reconstruction case, it was found that the tibial guide was off target.This targeting issue resulted in having to open another acl tray with proper tibial guides to ensure success in the formation and alignment for the tibial tunnel.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3,h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found the following warnings and precautions related to the reported failure: read these instructions completely prior to use.As with any surgical device, careful attention should be exercised to ensure that excessive force is not placed on this device.Excessive force can result in failure of this device.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10, h3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.Per e-mail communication, a break was also reported on the tray.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use for the tray was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review for the tray found that the reported failure was documented appropriately, and there were no indications to suggest that the anticipated risk region is not adequate.A review of the tray drawing found that no labelling in the tray is designated for a tibial aimer.The instruments are not supplied by the tray manufacturer.Insufficient product identification information was provided for the tibial guide, and thus, an instructions for use review could not be conducted.Insufficient product identification information was provided for the tibial guide, and thus, an risk management review could not be conducted.A visual inspection of the returned device found that it is not in its original packaging.There are markings on the lid confirming the product identification information.The device is worn from use, and only the tray was received.There is tape on one of the inner plastic trays the tape is holding a broken piece of the plastic in place.The complaint of a break was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, an impact event inconsistent with normal use, wear from prolonged use, misuse or rough handling, or inadequate routine maintenance.The complaint of an off-target tibial guide was not confirmed.Factors that could have contributed to the reported event include failure of a concomitant device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: TRAY ACUFEX DIRECTOR ELITE
• Common Device Name: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 11385544
• Report Number: 3003604053-2021-00062
• Device Sequence Number: 16989729
• Product Code: KCT
• UDI-Device Identifier: 03596010608178
• UDI-Public: 03596010608178
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K073551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2022

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: 72201731
• Device Catalogue Number: 72201731
• Device Lot Number: 21800001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 04/01/2021; 03/21/2022
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/07/2021; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown