• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK IMPLANT Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPEEDSET-US FULL DOSE 10 PK
Type of DeviceIMPLANT
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 Key4870155
MDR Text Key19806312
Report Number0002249697-2015-02113
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK063857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2016
Device Catalogue Number61921010
Device LOT NumberDBW006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/18/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/25/2015 Patient Sequence Number: 1
-
-