MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. PULSAVAC; LAVAGE, JET

Model Number 00-5150-475-00

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2020

Event Type  malfunction  

Event Description

Upon opening the sterile package of the pulsavac plus wound debridement system, i noticed a brown solution smeared on the handle of the equipment.Another package was opened with same reference but different lot number and this one was in good condition.Handle of equipment soiled while still in enclosed sterile package.No sterile field or patient exposure.Saved for or quality.

• Brand Name: PULSAVAC
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.; 56 east bell drive; warsaw IN 46581
• MDR Report Key: 10378420
• MDR Text Key: 202012436
• Report Number: 10378420
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00889024375154
• UDI-Public: (01)00889024375154(17)221231(10)64610793
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-5150-475-00
• Device Catalogue Number: 00-5150-475-00
• Device Lot Number: 64610793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1