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

Catalog Number	03.702.215S
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on an unknown date, the syringes were not able to be filled with the cement.The procedure was completed with replacements.They were not able to identify possible cause(s) such as hardened cement or device defectiveness.No further information is available.This report is for one (1) vertecem v+ syringe kit.This is report 1 of 2 for (b)(4).

• Brand Name: VERTECEM V+ SYRINGE KIT
• Common Device Name: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12174470
• Report Number: 8030965-2021-05770
• Device Sequence Number: 16384035
• Product Code: NDN
• UDI-Device Identifier: 07611819396074
• UDI-Public: (01)07611819396074
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.702.215S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1