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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT
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OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT Back to Search Results
Catalog Number 07.702.016S
Device Problem Failure to Eject (4010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2019
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown biomaterial - cement: vertecem/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that there was an issue with two (2) cement kits.Cement could not be properly filled into syringe.It was only possible by using force or not possible at all.Surgery was successfully completed with smaller amount of cement.There was no harm to patient.Concomitant medical product: unknown vertecem v+ syringe kit ( part# unknown, lot# unknown, quantity unknown).This report is for one (1) unk - biomaterial - cement: vertecem this is report 1 of 2 for complaint (b)(4).
 
Manufacturer Narrative
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
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 site: cq zuchwil.Selected flow: device interaction/ functional.Visual inspection: the received device was found stuck.The handle is not movable at all.There is some cement visible at the mixing and transfer lid which is an indication that the cement has been partially transferred.Function test: a functional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Dimensional inspection: a dimensional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Document/ specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Conclusion: this complaint was rated as confirmed as the device iwas found stuck and not functionally anymore.Based on the findings above we assume that a user error likely has led to the malfunction of the device.This production lot (9a53271) was manufactured in may 2019 according to the specification and with no non-conformities reported.No manufacturing related issues that would have contributed to this complaint were found.In order to avoid complications during mixing and transfer of cement we would like to draw your attention to the respective instruction for use se_386348 and the surgical technique 036.000.895.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities based on the information available, it has been determined that no corrective and/or preventive action is proposed.Device history lot part: 07.702.016s.Lot: 9a53271.Manufacturing site: selzach.Supplier: osartis gmbh.Release to warehouse date: (b)(6) 2019.Expiry date: jan 01, 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Device was used for treatment, not diagnosis.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
VERTECEM V+ CEMENT KIT
Type of Device
POLYMETHYLMETHACRYLATE BONE CEMENT
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9209738
MDR Text Key163335113
Report Number8030965-2019-69467
Device Sequence Number1
Product Code NDN
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,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/2022
Device Catalogue Number07.702.016S
Device Lot Number9A53271
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Date Manufacturer Received12/27/2019
Patient Sequence Number1
Treatment
UNK - BIOMATERIAL - CEMENT DELIVERY DEVICES: SPINE
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