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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSETGMV ENDURANCE GENT 40G; BONE CEMENT : BONE CEMENT

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DEPUY CMW - 9610921 SMARTSETGMV ENDURANCE GENT 40G; BONE CEMENT : BONE CEMENT Back to Search Results
Catalog Number 3105040
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint states: ¿event: the product had a problem.¿ the customer returned the sample for examination, (b)(4).Photographs were taken by the warsaw complaint team and confirm that the product problem is a broken ampoule.The pictures show an ampoule and blister packaging.The blister packaging shows green discolouration - a sign of contact with monomer.The ampoule has developed a crack approximately 3mm across the bottom.Retained samples from this lot number were checked for signs of this failure mode, but no further broken ampoules were discovered.Fmea dva-107020-fde rev 6 lines 115 and 116 refer to this failure mode, (b)(4)¿.The risk is considered ¿as low as possible¿ and cannot be further mitigated.In conclusion, this is a known failure mode and the current rate of complaints for this issue is within the expected occurrence rate.In confirmed reports of this issue, the most probable root cause can be traced to transport or storage.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.The number of complaints received for this failure mode will continue to be monitored and product updates/ recommendations will be implemented at the post market surveillance review dependent upon occurrence ratings.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The pictures show an ampoule and blister packaging.The blister packaging shows green discolouration - a sign of contact with monomer.The ampoule has developed a crack approximately 3mm across the bottom.Product information: bone cement; cod: 3105-040; lot #: 8679581.
 
Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  investigation summary : the complaint states: ¿event: the product had a problem.¿ the customer returned the sample for examination, see attachment ¿pc-000437855 photos.Pdf¿.Photographs were taken by the warsaw complaint team and confirm that the product problem is a broken ampoule.The pictures show an ampoule and blister packaging.The blister packaging shows green discolouration - a sign of contact with monomer.The ampoule has developed a crack approximately 3mm across the bottom.Retained samples from this lot number were checked for signs of this failure mode, but no further broken ampoules were discovered.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
SMARTSETGMV ENDURANCE GENT 40G
Type of Device
BONE CEMENT : BONE CEMENT
Manufacturer (Section D)
DEPUY CMW - 9610921
cornford rd
blackpool FY4 4 QQ
UK  FY4 4QQ
MDR Report Key8772255
MDR Text Key150582135
Report Number1818910-2019-97836
Device Sequence Number1
Product Code MBB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number3105040
Device Lot Number8679581
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Initial Date Manufacturer Received 07/09/2019
Initial Date FDA Received07/09/2019
Supplement Dates Manufacturer Received07/09/2019
Supplement Dates FDA Received07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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