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

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.

• 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 Key: 8772255
• MDR Text Key: 150582135
• Report Number: 1818910-2019-97836
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 3105040
• Device Lot Number: 8679581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1