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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO PCD: LONG 90 EXTENTION TUBE; MIXER, CEMENT, FOR CLINICAL USE
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STRYKER INSTRUMENTS-PUERTO RICO PCD: LONG 90 EXTENTION TUBE; MIXER, CEMENT, FOR CLINICAL USE Back to Search Results
Catalog Number 0506486000
Medical Device Problem Code Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/20/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported by the customer that the sterility of the device packaging is being compromised by a loose item inside of the box.There was no associated procedure and therefore, no patient involvement.
 
Event or Problem Description
It was reported by the customer that the sterility of the device packaging is being compromised by a loose item inside of the box.There was no associated procedure and therefore, no patient involvement.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
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Brand Name
PCD: LONG 90 EXTENTION TUBE
Common Device Name
MIXER, CEMENT, FOR CLINICAL USE
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo MI 00615
MDR Report Key8178692
Report Number0001811755-2018-02837
Device Sequence Number16650230
Product Code JDZ
UDI-Device Identifier34546540518096
UDI-Public34546540518096
Combination Product (Y/N)N
Initial Reporter CountryES
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/08/2019
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 No Information
Device Catalogue Number0506486000
Device Lot Number18167012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Initial Date Received by Manufacturer 11/20/2018
Supplement Date Received by Manufacturer01/16/2019
Initial Report FDA Received Date12/19/2018
Supplement Report FDA Received Date02/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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