MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OUTSIDE-IN MEDICAL REPAIR SYSTEM, MENISCUS MENDER II ; PASSER

Model Number 7209485

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Event Description

The handle of the snare within the smith & nephew meniscus mender ii (ref# 7209485) is breaking off from the stem of the snare when removing from the sterile packaging prior to use.Fda safety report id # (b)(4).

• Brand Name: OUTSIDE-IN MEDICAL REPAIR SYSTEM, MENISCUS MENDER II
• Type of Device: PASSER
• Manufacturer (Section D): SMITH & NEPHEW, INC. ; andover MA 01810
• MDR Report Key: 9426220
• MDR Text Key: 169857729
• Report Number: MW5091496
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/03/2019

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 Model Number: 7209485
• Device Catalogue Number: 7209485
• Device Lot Number: 2034277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 67