MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GEN 3.5 ARTHROSCOPIC BIOINDUCTIVE LARGE; MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON

Catalog Number	4566
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when deploying the large regeneten, it seemed to be loaded upside down.The blue border was on top but no metal feet to keep it in place was seen on the top side.The customer is not sure if it was a fluke or if some how it happened as they rocked the device back and forth for it to fully open up.It was removed by pulling out the deployment device and a new one was opened.No further information related with the patient is available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: review of the applicable dhrs did not indicate any nonconformance, deviations or other issues with devices involved in this issue.A complete review of manufacturing documentation was conducted and the devices were found to be within specification.Complaint history indicates that are no similar complaints received related to the implant loaded upside down.The risk associated with the complaint are already included in the risk analysis.Device labeling was reviewed.All instructions for use and product labels were found to be current, complete and comprehensive.The products, used for treatment, were not returned for evaluation and therefore a physical investigation could not be completed.Failure mode experienced by the user facility were unable to be confirmed through direct physical investigation.In conclusion, there is insufficient information to determine a root cause.No relevant clinical information or photos were provided for inclusion in the medical investigation.However, per subsequent e-mail, ¿the faulty device was removed by pulling out the deployment device and a new one was opened.¿ since the procedure completed with a backup device, without delay or harm to the patient, no further clinical/medical assessment is warranted at this time.Should additional relevant clinical information be provided, this complaint will be re-assessed.No further investigation is warranted at this time.Investigation will be revisited if additional information is received.Although the issues experienced by the user facility were unable to be confirmed through direct physical investigation, the issue will be monitored for trending purposes.

• Brand Name: GEN 3.5 ARTHROSCOPIC BIOINDUCTIVE LARGE
• Common Device Name: MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10112899
• Report Number: 3003604053-2020-00050
• Device Sequence Number: 2626208
• Product Code: OWY
• UDI-Device Identifier: 00885556735664
• UDI-Public: 885556735664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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 Expiration Date: 12/10/2022
• Device Catalogue Number: 4566
• Device Lot Number: A7737
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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: Required Intervention