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

Catalog Number 61921010

Device Problems Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Shipped to facility and the outer box was damaged.Inside of box was damaged also.As per initial reporter on (b)(6) 2016: the ampoules were smashed, you could hear broken glass sliding around.

Manufacturer Narrative

An event regarding packaging damage involving simplex bone cement was reported.The event was confirmed based on the photograph provided.Method & results: device evaluation and results: no product was returned for evaluation however a photograph was provided which shows extensive damage to the sides of the shipper box and the 10-pack of bone cement within.The shipper box appears to have been crushed in transit.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: review of the batch manufacturing record indicates that this batch was manufactured and shipped to stock with no reported discrepancies.Complaint history review: review determined that there were no other similar reported events for the lot.Conclusions: no product was returned for evaluation however a photograph was provided which shows extensive damage to the sides of the shipper box and the 10-pack of bone cement within.The shipper box appears to have been crushed in transit.A capa trend analysis was conducted for the reported failure mode and concluded simplex packaging damage may result from other factors not necessarily related to the product.No further investigation is possible at this time as no product and insufficient information was received by stryker orthopaedics.If additional information becomes available this investigation will be reopened.

Event Description

Shipped to facility and the outer box was damaged.Inside of box was damaged also.As per initial reporter on 8/25/2016: the ampoules were smashed, you could hear broken glass sliding around.

• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5929809
• MDR Text Key: 54484431
• Report Number: 0002249697-2016-02855
• Device Sequence Number: 1
• Product Code: MBB
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 61921010
• Device Lot Number: DDX007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• 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