MAUDE Adverse Event Report: SYNTHES GMBH VERTECEM V+ CEMENT KIT; DISPENSER, CEMENT

Catalog Number 07.702.016S

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in china as follows: it was reported that the vertecem v+ cement kit had connection issues.It was reported that during the surgery, the shell cover is blocked and cannot be connected to the rotary valve funnel.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.This complaint involves one (1) device.This report is for one (1) vertecem v+ cement kit this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint# (b)(4).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.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reportr state: nantong.Initial reporter is a j&j sales representative.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 history lot part: 07.702.016s.Lot no: 2d53501.Release to warehouse: 05 april, 2022.Expiry date:01 april, 2025.Manufacturing site: werk selzach.Supplier: osartis gmbh.A manufacturing record evaluation was performed for the finished article lot 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: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17041020
• MDR Text Key: 316344007
• Report Number: 8030965-2023-06963
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 2D53501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1