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

Catalog Number 07.702.016S

Device Problem Improper Chemical Reaction (2952)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

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 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), 2021, a percutaneous vertebroplasty (l1) treating vertebral centrum fracture was performed.While the surgeon was operating the handle to mix up cement, the handle became jammed.The procedure was completed with a thirty (30) minute surgical delay.No further information is available.This report is for one (1) vertecem v+ cement kit.This is report 1 of 1 for (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.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed sistema de cemento vertecem v+.Esteril the cement was solidified, and no other issues were identified.The dimensional inspection was not performed due to alleged complaint condition.The observed condition of sistema de cemento vertecem v+.Esteril in the device was consistent with the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for sistema de cemento vertecem v+.Esteril.While no definitive root cause could be determined, there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part: 07.702.016s.Lot: 1b53380.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 02 february 2021.Expiration date: 01 february 2024.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: POLYMETHYLMETHACRYLATE BONE 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: dan nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 12555545
• MDR Text Key: 281205577
• Report Number: 8030965-2021-08170
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819376250
• UDI-Public: (01)07611819376250
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 07.702.016S
• Device Lot Number: 1B53380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1