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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH SPEEDSET-US FULL DOSE 10 PK BONE CEMENT, ANTIBIOTIC Back to Search Results
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). ".

 
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Brand NameSPEEDSET-US FULL DOSE 10 PK
Type of DeviceBONE 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 Key8780008
MDR Text Key150733566
Report Number0002249697-2019-02552
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 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 Received07/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/31/2020
Device Catalogue Number61921010
Device LOT NumberDGZ024
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/07/2018
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: 07/11/2019 Patient Sequence Number: 1
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