MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE WITH SOFT TISSUE TIP; LAVAGE, JET

Catalog Number	0210112000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
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: 2 events were reported for this quarter.Product return status: 1 device was received.1 device investigation type has not yet been determined.Event confirmation status: 1 reported event was confirmed.Evaluation results 1 device was found to be affected by a manufacturing issue.2 devices were labeled for single-use.2 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.2 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had a component detach.2 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 2 previously reported events are included in this follow-up record.Product return status 2 devices were received.Event confirmation status 2 reported events were confirmed.Evaluation results 1 device was found to be affected by a manufacturing issue.1 device was found to be affected by a detached end tip.

• Brand Name: INTERPULSE HANDPIECE WITH SOFT TISSUE TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9996937
• Report Number: 0001811755-2020-01052
• Device Sequence Number: 4442502
• Product Code: FQH
• UDI-Device Identifier: 34546540144233
• UDI-Public: 34546540144233
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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): 07/30/2020

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: 0210112000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1