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 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device malfunctioned intra-operatively and was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter telephone not available for reporting 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.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 the vertecem v+ cement kit was used in an unknown surgical procedure on (b)(6) 2018.The filling of the monomer was carried out without loss.When mixing the cement, the blue mixing piston dissipated with difficulty, causing additional force in order to mix.Filling of the syringes over the three-way faucet was also difficult, resulting in only four (4) syringes being reared with force.It was presumed the cement had hardened prematurely.Another vertecem v+ cement kit was opened and the mixing and filling of the syringes were completed without difficulty.Surgery was completed successfully with a delay of approximately 10 minutes and no impact to the patient.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.A device history record review was performed for the subject device: part number: 07.702.016s , synthes lot number: 7g53211.Manufacturing location: selzach , supplier: aap biomaterials gmbh , release to warehouse date: 16.Oct.2017 expiry date: 31.July 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.A product development investigation was performed for the subject device: the returned cement kit was forwarded to the supplier for evaluation.The statement below is a summary of their investigation.We have analyzed retain samples of the affected batch in our laboratory without any deviations.The application testing shows comparable results as for the final control of this batch, all results are within the specified values.Also, the batch and qc documentation of the affected batch shows no deviation.The description of the failure could indicate a temperature issue during conditioning of the cement unit for the procedure.The viscosity of the cement depends strongly from the temperature.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.

• 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: 7520072
• MDR Text Key: 108490550
• Report Number: 8030965-2018-53809
• 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,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 7G53211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 05/18/2018; 06/29/2018
• Supplement Dates FDA Received: 06/08/2018; 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1