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

Catalog Number	0210114000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
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: 7 events were reported for this quarter.Product return status: 7 device investigation types have not yet been determined.Additional information: 7 devices were labeled for single-use.7 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 7 malfunction events in which the device had a component detach.7 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 7 malfunction events in which the device had a component detach.- 7 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 7 previously reported events are included in this follow-up record.Product return status 7 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12680387
• Report Number: 3015967359-2021-02359
• Device Sequence Number: 4126823
• 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: 7
• 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): 01/20/2022

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
• Device Catalogue Number: 0210114000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown