MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. HEMOVAC WOUND DRAINAGE SYSTEM; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 00256900010

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2020

Event Type  malfunction  

Event Description

A drain was placed during a l1-4 direct lateral lumbar interbody fusion surgery.Four days post-operatively, the neurosurgery team attempted to remove the drain.The drain fractured.The patient was taken to the or for a removal of the drain.The patient tolerated the procedure well and was discharged from the hospital as planned two days later.

• Brand Name: HEMOVAC WOUND DRAINAGE SYSTEM
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 10733112
• MDR Text Key: 213004800
• Report Number: 10733112
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00256900010
• 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: 10/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• 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: 28105 DA
• Patient Weight: 55