MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH VERTECEM V+ SYRINGE KIT; CEMENT DISPENSER

Catalog Number 03.702.215S

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; 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) 2019, the tip of the white vertecem syringe kit broke while removing from cement reservoir (vercetem v+ cement kit) during an unknown procedure.The surgical procedure was successfully completed although it is unknown how was the procedure completed.There were no surgical delay and patient consequence reported.Concomitant device reported: vercetem v+cement kit (part# 07.702.016s, lot# unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Event Description

It was further reported the surgeon used the other syringes on the set to successfully complete procedure.

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: device history records review was completed for part: 03.702.215s, lot: 8102588.Manufacturing location: selzach, release to warehouse date: dec 16, 2018, expiry date: oct 01, 2023.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.H3, h6: complaint is confirmed based on the provided photographs.It is visible that the tip of the syringe is missing/broken.H11 correction data: e1: reporter facility country code and phone number.E1: initial reporter is synthes sales representative.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+ SYRINGE KIT
• Type of Device: CEMENT DISPENSER
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8387978
• MDR Text Key: 137827867
• Report Number: 8030965-2019-61711
• Device Sequence Number: 1
• Product Code: OAR
• UDI-Device Identifier: 07611819396074
• UDI-Public: (01)07611819396074
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 03.702.215S
• Device Lot Number: 8102588
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1