MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ CEMENT KIT; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.Reporter phone number is not provided for reporting.The 510k: device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 europe reports an event in (b)(6) as follows: it was reported that during an unknown spine procedure performed on (b)(6) 2018, the blue mixing handle of the vertecem v+ mixer could not be moved and thus cement could not be mixed.Therefore, a second kit was opened and the cement could be mixed with the second kit but only with a lot of force.The new cement kit had to be opened to complete the procedure.Surgery was delayed for approximately ten (10) minutes in order to open the new kit.Procedure was completed successfully with no patient harm.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.A device history record review was performed for the subject device: part number: 07.702.016s.Synthes lot number: 7c53190.Manufacturing location: selzach.Supplier: (b)(4).Release to warehouse date: 14.Jun.2017.Expiry date: 01.Mar.2020.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

• 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 Key: 7335647
• MDR Text Key: 102274407
• Report Number: 8030965-2018-52013
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250(17)200301(10)7C53190
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 7C53190
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1