MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P - US FULL DOSE 10-PK; BONE CEMENT

Catalog Number 61911010

Device Problems Break (1069); Leak/Splash (1354); Shipping Damage or Problem (1570)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the batch manufacturing records indicates ten packs were manufactured and accepted into final stock with no relevant reported discrepancies.There has been one other similar event for the reported lot; the other event was reported under this pi, therefore no further trending activity is required.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.

Event Description

As reported, "box was opened at the hospital and 2 of the cements were leaking in box.".

• Brand Name: SIMPLEX P - US FULL DOSE 10-PK
• Type of Device: BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8043250
• MDR Text Key: 128249839
• Report Number: 0002249697-2018-03633
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 37613327128445
• UDI-Public: 37613327128445
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 61911010
• Device Lot Number: RFZ082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other