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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 Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 10/13/2016
Event Type  Malfunction  
Manufacturer Narrative

It was noted that the device is not available for evaluation. Additional information has been requested. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

 
Event Description

Per sales rep, the hospital ordered a box of bone cement speed set. There was a busted vial.

 
Manufacturer Narrative

An event regarding packaging damage involving simplex bone cement was reported. The event was confirmed based on photographs provided. Method & results: -device evaluation and results: no product was returned for evaluation however photographs were provided which shows discoloration to the shipper box and 10 pack carton. There are also photographs showing damage to the single unit pack as well as a deformed blister with the tyvek lid removed and a broken vile. When the ampoule was broken the monomer leaked out causing the damage to the packaging and to both the tyvek seal and the blister. This damage is consistent with excessive inappropriate handling. -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 photographs were provided which shows discoloration to the shipper box and 10 pack carton. There are also photographs showing damage to the single unit pack as well as a deformed blister with the tyvek lid removed and a broken vile. When the ampoule was broken the monomer leaked out causing the damage to the packaging and to both the tyvek seal and the blister. This damage is consistent with excessive inappropriate handling. 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

Per sales rep, the hospital ordered a box of bone cement speed set. There was a busted vial.

 
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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
keyla colon
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6090234
MDR Text Key59514742
Report Number0002249697-2016-03549
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2018
Device Catalogue Number61921010
Device LOT NumberDGX017
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 Received12/07/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/25/2016
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: 11/09/2016 Patient Sequence Number: 1
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