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

Catalog Number 7209485

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2020

Event Type  malfunction  

Event Description

It was reported that during the set up of an knee arthroscopy with meniscal repair procedure, the shafts of both loop-ended stylets were detached from the proximal metal ends.Procedure was completed with the same device.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6: the reported disposable meniscus mender ii kit, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.An exact root cause cannot be determined with confidence without the return of the device.However, a trend of this nature has been observed with this product in the field, prompting a root cause investigation.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint records was performed for the reported device, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SET MENISCUS MENDER II DISPOSABLE
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10068082
• MDR Text Key: 191387229
• Report Number: 1219602-2020-00794
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 03596010468482
• UDI-Public: 3596010468482
• Combination Product (y/n): N
• PMA/PMN Number: K885311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 7209485
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 06/12/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1