MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. HEMOVAC; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 00-2569-000-10

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

The patient underwent l5 to s1 lumbar spine fusion surgery and a lumbar drain was placed.The drain was being removed on post-operative day four when it fractured.The patient returned to the or for removal of the fractured piece.

• Brand Name: HEMOVAC
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio ave.; dover OH 44622
• MDR Report Key: 10762413
• MDR Text Key: 213867850
• Report Number: 10762413
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/20/2020,10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-2569-000-10
• Device Catalogue Number: 00-2569-000-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19345 DA
• Patient Weight: 59