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); Component or Accessory Incompatibility (2897)

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

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.The device has been 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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, product vertecem v+ was used as described in the surgical technique, but there was a mechanical error of pushing and pulling the handle which was stacked inside the blue handle part and the nurse was not able to mix the powder with monomer, which was placed inside of the mixing white part.Nurse could not perform oscillating-rotating movement.Thus the cement could not be mixed.There was surgical delay of five (5) minutes reported.No patient consequences were reported.Competitive product had to be mixed and used as we did not have another product on consignment stock.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 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.H3, h4, h6: part 07.702.016s, lot 0d53340: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: september 01, 2020.Expiry date: april 01, 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: the complaint sample clearly shows user error.The mixing chamber was reduced too early, before the mixing was finished.So, the mixer could no ionger be driven back and forth.For this reason, we cannot do any further action.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.The root cause was identified during the performed supplier evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.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.H11: corrected data: g1: physical manufacturer.

• 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: 10693520
• MDR Text Key: 212324683
• Report Number: 8030965-2020-08029
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 0D53340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 12/14/2020
• Patient Sequence Number: 1