MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO PCD: LONG 90 EXTENTION TUBE; MIXER, CEMENT, FOR CLINICAL USE

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.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
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.

• 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 Key: 8178693
• Report Number: 0001811755-2018-02836
• Device Sequence Number: 11339641
• Product Code: JDZ
• UDI-Device Identifier: 34546540518096
• UDI-Public: 34546540518096
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• 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: Health Professional
• Device Catalogue Number: 0506486000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1