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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH BONE CLEANING TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH BONE CLEANING TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210110000
Medical Device Problem Code Delivered as Unsterile Product (1421)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/27/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported there was a foreign substance in the sterile packaging prior to a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported there was a foreign substance in the sterile packaging prior to a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
INTERPULSE HANDPIECE WITH BONE CLEANING 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 Key8432513
Report Number0001811755-2019-00872
Device Sequence Number16379254
Product Code FQH
UDI-Device Identifier34546540683831
UDI-Public34546540683831
Combination Product (Y/N)N
Initial Reporter CountryKR
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/23/2019
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 Number0210110000
Device Lot Number17338012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2019
Initial Date Received by Manufacturer 02/27/2019
Supplement Date Received by Manufacturer04/17/2019
Initial Report FDA Received Date03/19/2019
Supplement Report FDA Received Date04/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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