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	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: lod.Cement remained implanted as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part: 08.702.017s; lot: 8d60110; manufacturing site: (b)(4); supplier: (b)(4); release to warehouse date: 09.Aug.2018; expiry date: 31.Oct.2019.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all specified criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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 during an unknown procedure on (b)(6) 2018, upon mixing and opening the mixer to dispense, vertecem cement spilled out of the mixer as if under pressure.This happened to two (2) mixers and seemed to have pressure in mixing valve.Cement came out before stop cock could be applied but once stop cock was attached everything was fine.This might be due to a technical error in mixing aggressively on the back table.Sufficient cement remained and was of normal viscosity, so there was no impact on the patient and no delay on the length of the procedure.The procedure was completed successfully without further incident and the patient outcome was good.This report is for one (1) vertecem ii mixing kit-sterile.This is report 1 of 2 for complaint (b)(4).

• 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: 8006460
• Report Number: 2939274-2018-54618
• Device Sequence Number: 203560
• Product Code: NDN
• UDI-Device Identifier: 04260056880759
• UDI-Public: (01)04260056880759
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121876
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/11/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/25/2018
• Patient Sequence Number: 1
• Patient Age: 68 YR