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

Catalog Number	0210114000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 3 events were reported for this quarter.Product return status: 2 devices were received.1 device investigation type has not yet been determined.Event confirmation status: 2 reported events were confirmed.Evaluation results: 1 device was found to be affected by foreign material in the sterile packaging.1 device did not have a root cause established.Additional information: 3 devices were labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device had debris in sterile package.3 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 3 previously reported events are included in this follow-up record.Product return status 3 devices were received.Event confirmation status 3 reported events were confirmed.Evaluation results 1 device was found to be affected by an issue with manufacturing.2 devices did not have a root cause established.
Event or Problem Description
This report summarizes 3 malfunction events in which the device had debris in sterile package.3 events had patient involvement; no patient impact.

• Brand Name: INTERPULSE HANDPIECE WITH HIGH FLOW TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; PR 00615
• MDR Report Key: 9245005
• Report Number: 0001811755-2019-03410
• Device Sequence Number: 13916761
• Product Code: FQH
• UDI-Device Identifier: 34546540673566
• UDI-Public: 34546540673566
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: No Information
• Device Catalogue Number: 0210114000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1