MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TRAUMACEM(TM) V+ SYRINGE KIT - STERILE; DISPENSER, CEMENT

Model Number	03.702.150S
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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 on an unknown date in 2021, patient underwent orthopedic procedure.During a right femur trochanteric fixation nail-advanced (tfna) insertion the surgeon requested traumacem.During the preparation of the traumacem, the tech had difficulty mixing the cement, he was unable to compress the t handle to "fully compressed stop" position.The cement was difficult to load into the small syringe and the doctor was unable to inject the cement into the tfna lag screw.Surgeon abandoned the cement implantation.There was a (5) minutes of surgical delay noted.The procedure was successfully completed.There was no patient consequences.This report is for (1) traumacem(tm) v+ syringe kit - sterile.This is report 1 of 2 for complaint (b)(4).

• Brand Name: TRAUMACEM(TM) V+ SYRINGE KIT - STERILE
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12463598
• Report Number: 2939274-2021-05386
• Device Sequence Number: 19131306
• Product Code: KIH
• UDI-Device Identifier: 10886982262233
• UDI-Public: (01)10886982262233
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

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 Model Number: 03.702.150S
• Device Catalogue Number: 03.702.150S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 91