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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH SOFT TISSUE TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH SOFT TISSUE TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210112000
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/13/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device had a broken battery housing port during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the device had a broken battery housing port during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
INTERPULSE HANDPIECE WITH SOFT TISSUE 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 Key9145426
Report Number0001811755-2019-03151
Device Sequence Number19488463
Product Code FQH
UDI-Device Identifier34546540144233
UDI-Public34546540144233
Combination Product (Y/N)N
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/21/2019
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 Number0210112000
Device Lot Number18348012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Initial Date Received by Manufacturer 09/25/2019
Supplement Date Received by Manufacturer11/21/2019
Initial Report FDA Received Date10/02/2019
Supplement Report FDA Received Date11/21/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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