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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
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: 3 devices were received.Event confirmation status: 3 reported events were confirmed.Evaluation results: 1 device was found to be affected by white particles on the device tubing.2 devices did not have a root cause established.3 devices were labeled for single-use.3 devices were not reprocessed or 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.
Event or Problem Description
This report summarizes 4 malfunction events in which the device had debris in sterile package.4 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: b5, h10 3 events were originally reported for this failure mode during the reporting quarter.1 event was inadvertently excluded.4 reported events are included in this follow-up record.Product return status: 4 devices were received.

• 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 ; * 00615
• MDR Report Key: 10748435
• Report Number: 0001811755-2020-02863
• Device Sequence Number: 11514858
• 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: 4
• 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): 01/29/2021

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: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1