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

Catalog Number	61921010
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8780008
• Report Number: 0002249697-2019-02552
• Device Sequence Number: 16737841
• Product Code: MBB
• UDI-Device Identifier: 37613327128452
• UDI-Public: 37613327128452
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K063857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 61921010
• Device Lot Number: DGZ024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other