MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK; IMPLANT

Catalog Number 61921010

Device Problems Device Emits Odor (1425); Shipping Damage or Problem (1570); Device Packaging Compromised (2916); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

Fed ex delivered bone cement shipment that had smell coming from box.Hospital did not open the box to see how many vials were broken.Hospital contacted our office to say that they would be disposing of cement immediately and needed a new box shipped.

Manufacturer Narrative

An evaluation of the device cannot be performed as the cement was disposed of by the hospital and was not returned to the manufacturer.Additional information has been requested.Should additional information become available, it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.

Manufacturer Narrative

An event regarding packaging damage involving simplex packaging was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as no devices or photographs were provided for review.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: based on the information provided by the customer, there was an odour coming from the product when the reported damage was noted upon receipt at the hospital.This indicates that an ampoule(s) was broken at the time or shortly before the product was received by the customer as the smell would have come from the monomer when the ampoule was broken.This odour from the monomer liquid lasts a short period of time as the liquid evaporates when exposed to the atmosphere.Based on the information provided, it appears that this product was damaged due to inappropriate handling during distribution/transportation.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.If product and/or additional information becomes available this investigation will be reopened.

Event Description

(b)(6) delivered bone cement shipment that had smell coming from box.Hospital did not open the box to see how many vials were broken.Hospital contacted our office to say that they would be disposing of cement immediately and needed a new box shipped.

• Brand Name: SPEEDSET-US FULL DOSE 10 PK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK (MDR); raheen business park; limerick NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4870155
• MDR Text Key: 19806312
• Report Number: 0002249697-2015-02113
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 61921010
• Device Lot Number: DBW006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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