MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO PCD KIT: LONG 90, 11G MATCH-GROUND W/ BEVEL; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0506483000
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/24/2019
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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device is labeled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was reported found to have a tear, rip, or hole in the device packaging.1 event had no 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 1 previously reported event is included in this follow-up record.Product return status 1 device was received.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device was found to be affected by a manufacturing process issue.
Event or Problem Description
This report summarizes 1 malfunction event in which the device was reported found to have a tear, rip, or hole in the device packaging.1 event had no patient involvement; no patient impact.

• Brand Name: PCD KIT: LONG 90, 11G MATCH-GROUND W/ BEVEL
• 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: 8816613
• Report Number: 0001811755-2019-02528
• Device Sequence Number: 16229080
• Product Code: JDZ
• UDI-Device Identifier: 34546540907012
• UDI-Public: 34546540907012
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• 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): 01/02/2020

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 Number: 0506483000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1