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

Catalog Number 07.702.016S

Device Problems Chemical Problem (2893); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 on (b)(6) 2020, during a vertebroplasty procedure, the surgeon could not push the handle of the vertecem cement kit.The procedure was completed using another device.There was no patient consequence.There is no further information available.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for (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.H6: we have forwarded the complaint available data to the supplier for further investigation.Please find an extract of the investigation outcome below: the video clearly shows a user error where the mixing chamber was reduced too early.The chamber was reduced before the mixing process was finalized.For this reason we cannot do any further action.We recommend user training by synthes field services.Allover summary: product was not returned.Reviewing attached picture and video the reported complaint condition can be confirmed.Based on supplier investigation outcome and 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.H6: a device history record (dhr) review was conducted: part: 07.702.016s, lot: 9f53300, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 25.Oct.2019, expiry date: 01.June 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

• 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: 10824111
• MDR Text Key: 215990132
• Report Number: 8030965-2020-08863
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 9F53300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Removal/Correction Number: N/A
• Patient Sequence Number: 1