MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC VERTECEM II MIXING KIT-STERILE; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number	08.702.017S
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: lod.Complainant part is not expected to be returned for manufacturer review/investigation.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 or Problem Description
It was reported that a patient underwent unknown procedure at level t8 on (b)(6) 2019 due to vertebral compression fractures.During the procedure the surgical tech was trying to mix the vertecem ii mix kit.The t-handle was stuck and never allowed her to mix.It is unknown if there was a surgical delay.There were no adverse consequences to the patient reported.Procedure and patient outcome are unknown.This report is for one (1) vertecem ii mixing kit-sterile.This is report 1 of 1 for complaint (b)(4).
Additional 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 (dhr) review was conducted: part: 08.702.017s.Lot: 8d60110.Manufacturing site: selzach.Supplier: osartis gmbh.Release to warehouse date: 09.Aug.2018.Expiry date: 31.Oct.2019.A manufacturing record evaluation was performed for the finished device lot number, 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 II MIXING KIT-STERILE
• Common Device Name: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8546245
• Report Number: 2939274-2019-57623
• Device Sequence Number: 2443153
• Product Code: NDN
• UDI-Device Identifier: 04260056880759
• UDI-Public: (01)04260056880759
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K121876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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 Expiration Date: 10/31/2019
• Device Model Number: 08.702.017S
• Device Catalogue Number: 08.702.017S
• Device Lot Number: 8D60110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/21/2019
• Patient Sequence Number: 1
• Patient Age: 80 YR