MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH BONE CLEANING TIP; LAVAGE, JET

Catalog Number	0210110000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported, after the saline bag was spiked, fluid leaked from the saline bag through the power box and all over the floor during a procedure.No medical intervention, no clinically significant delay and no adverse consequences.
Event or Problem Description
The user facility reported, after the saline bag was spiked, fluid leaked from the saline bag through the power box and all over the floor during a procedure.No medical intervention, no clinically significant delay and no adverse consequences.

• Brand Name: INTERPULSE HANDPIECE WITH BONE CLEANING TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 8176170
• Report Number: 0001811755-2018-02815
• Device Sequence Number: 11259534
• Product Code: FQH
• UDI-Device Identifier: 34546540683831
• UDI-Public: 34546540683831
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0210110000
• Device Lot Number: 18193012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1