MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET MENISCUS MENDER II DISPOSABLE; PASSER

Catalog Number	7209485
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.One of the suture retrievers had the snare fractured away from the shaft and hub.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).
Event or Problem Description
It was reported that during a knee surgery, the lasso of the set meniscus mender was introduced into the needle put into the knee of the patient to get back a thread.By trying to remove the system, the tip of the lasso remained in to the patient knee.The surgeon succeeded to get it back (no damage for the patient).The procedure was completed with a delay of 15 minutes.There is no information available of the back up of the set meniscus mender.No further complications were reported.

• Brand Name: SET MENISCUS MENDER II DISPOSABLE
• Common Device Name: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19215590
• Report Number: 1219602-2024-00909
• Device Sequence Number: 12788664
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 03596010468482
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K885311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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 Catalogue Number: 7209485
• Device Lot Number: 2131828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 72 KG