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

Catalog Number 07.702.016S

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that during a kyphoplasty procedure on (b)(6) 2019, it was impossible to mix the cement of a vertecem cement kit in the syringe.The cement hardened immediately.Procedure outcome and patient status are unknown.This report is for a vertecem v+ cement kit.This is report 1 of 1 for (b)(4).

Event Description

The procedure was completed successfully, using another cement kit.There was no surgical delay.

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.H3, h6: part: 07.702.016s, lot: 9e53291, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: august 30, 2019, expiry date: september 01, 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.We have forwarded the part to the responsible supplier for investigation, with the following results: the sawn open mixing system shows a too early reduction of the mixing chamber.The chamber was reduced before the mixing process was finalized.This led to a mixing piston that is difficult to move, what was recognized by the user as premature hardening of the cement.It is obvious that the mixing process was not finished and that the cement has not hardened because there were residues of cement powder at the peripheral areas of the mixing chamber and the cement has settled to one side and only then became solid.Since the batch documentation and the retained sample do not show any abnormalities, product failure is excluded.It is almost certainly a user error and therefore we recommend user training by the synthes field service.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 9576404
• MDR Text Key: 195122398
• Report Number: 8030965-2020-00241
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• 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: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 9E53291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Date Manufacturer Received: 01/14/2020
• Patient Sequence Number: 1