MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK; BONE CEMENT, ANTIBIOTIC

Catalog Number 61921010

Device Problem Shipping Damage or Problem (1570)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

6192-1-010 damaged during shipment ((b)(6)) to customer.3 vials broken and leaked on remaining doses.Update: "one complete ten pack.Customer reported damaged outer box.3 vials were broken and leaked on remaining 7 doses.Odor was coming from the product when received.Ten pack was received in a shipper/outer box and was packed appropriately to minimize movement.A report was filed with (b)(6).".

• Brand Name: SPEEDSET-US FULL DOSE 10 PK
• Type of Device: BONE CEMENT, ANTIBIOTIC
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8780008
• MDR Text Key: 150733566
• Report Number: 0002249697-2019-02552
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 37613327128452
• UDI-Public: 37613327128452
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 61921010
• Device Lot Number: DGZ024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2018
• 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