MAUDE Adverse Event Report: STRYKER 3.4MM GRASPER

Model Number 3.4MM GRASPER

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2016

Event Type  Injury  

Event Description

Arthroscopic loose body forceps chipped during surgical procedure on patient's knee, sending approximately 2cm piece into patient's soft tissue.Chipped piece was not able to be retrieved.Diagnosis or reason for use: repair of torn meniscus.Event abated after use stopped or dose reduced: no.

• Brand Name: 3.4MM GRASPER
• Type of Device: 3.4MM GRASPER
• Manufacturer (Section D): STRYKER
• MDR Report Key: 5445175
• MDR Text Key: 38530334
• Report Number: MW5060256
• Device Sequence Number: 1
• Product Code: NBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2016

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: 3.4MM GRASPER
• Device Catalogue Number: 300-034-701
• Other Device ID Number: 300-034-701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR